Trial Outcomes & Findings for Bioequivalence Study Between Levocetirizine Oral Disintegrating Tablet (ODT) and Levocetirizine Immediate Release Tablet (IRT) (NCT NCT03555890)
NCT ID: NCT03555890
Last Updated: 2020-06-02
Results Overview
Blood samples were collected to measure AUC(0-t) at indicated time-points. AUC(0-t) was calculated by the linear trapezoidal method (i.e., Linear Trapezoidal Linear Interpolation calculation method in Phoenix WinNonlin).
COMPLETED
PHASE1
72 participants
Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose
2020-06-02
Participant Flow
This was a single center, single dose, open-label, randomized, 2-part, 2-way crossover study. Bioequivalence (BE) between levocetirizine (levo) oral disintegrating tablet (ODT) and levocetirizine immediate release tablet (IRT) was evaluated in 72 healthy Japanese participants.
A total of 133 participants were screened, of them, 72 participants were randomized to receive study treatment. All participants except one participant randomized in Part 2 (Initial study) completed the study.
Participant milestones
| Measure |
Part 2:Levo ODT 5 mg (Without Water) Followed by Levo IRT 5 mg
All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods.
|
Part 1: Levo IRT 5 mg Followed by Levo ODT 5 mg (With Water)
All participants received a single oral dose of levocetirizine IRT 5 milligram (mg) tablet with water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods.
|
Part 1: Levo ODT 5 mg (With Water) Followed by Levo IRT 5 mg
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods.
|
Part 2:Levo IRT 5 mg Followed by Levo ODT 5 mg (Without Water)
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods.
|
|---|---|---|---|---|
|
Part 1:Treatment Period 1 (3 Days)
STARTED
|
0
|
12
|
12
|
0
|
|
Part 1:Treatment Period 1 (3 Days)
COMPLETED
|
0
|
12
|
12
|
0
|
|
Part 1:Treatment Period 1 (3 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part 1:Washout Period (at Least 5 Days)
STARTED
|
0
|
12
|
12
|
0
|
|
Part 1:Washout Period (at Least 5 Days)
COMPLETED
|
0
|
12
|
12
|
0
|
|
Part 1:Washout Period (at Least 5 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part 1:Treatment Period 2 (10 Days)
STARTED
|
0
|
12
|
12
|
0
|
|
Part 1:Treatment Period 2 (10 Days)
COMPLETED
|
0
|
12
|
12
|
0
|
|
Part 1:Treatment Period 2 (10 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part 2:Treatment Period 1 (3 Days)
STARTED
|
24
|
0
|
0
|
24
|
|
Part 2:Treatment Period 1 (3 Days)
COMPLETED
|
24
|
0
|
0
|
24
|
|
Part 2:Treatment Period 1 (3 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part 2:Washout Period (at Least 5 Days)
STARTED
|
24
|
0
|
0
|
24
|
|
Part 2:Washout Period (at Least 5 Days)
COMPLETED
|
23
|
0
|
0
|
24
|
|
Part 2:Washout Period (at Least 5 Days)
NOT COMPLETED
|
1
|
0
|
0
|
0
|
|
Part 2:Treatment Period 2 (10 Days)
STARTED
|
23
|
0
|
0
|
24
|
|
Part 2:Treatment Period 2 (10 Days)
COMPLETED
|
23
|
0
|
0
|
24
|
|
Part 2:Treatment Period 2 (10 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 2:Levo ODT 5 mg (Without Water) Followed by Levo IRT 5 mg
All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods.
|
Part 1: Levo IRT 5 mg Followed by Levo ODT 5 mg (With Water)
All participants received a single oral dose of levocetirizine IRT 5 milligram (mg) tablet with water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods.
|
Part 1: Levo ODT 5 mg (With Water) Followed by Levo IRT 5 mg
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods.
|
Part 2:Levo IRT 5 mg Followed by Levo ODT 5 mg (Without Water)
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods.
|
|---|---|---|---|---|
|
Part 2:Washout Period (at Least 5 Days)
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Bioequivalence Study Between Levocetirizine Oral Disintegrating Tablet (ODT) and Levocetirizine Immediate Release Tablet (IRT)
Baseline characteristics by cohort
| Measure |
Part 1: Levo IRT 5 mg Followed by Levo ODT 5 mg (With Water)
n=12 Participants
All participants received a single oral dose of levocetirizine IRT 5 milligram (mg) tablet with water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods.
|
Part 1: Levo ODT 5 mg (With Water) Followed by Levo IRT 5 mg
n=12 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods.
|
Part 2:Levo IRT 5 mg Followed by Levo ODT 5 mg (Without Water)
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods.
|
Part 2:Levo ODT 5 mg (Without Water) Followed by Levo IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
29.5 Years
STANDARD_DEVIATION 6.72 • n=39 Participants
|
31.8 Years
STANDARD_DEVIATION 8.93 • n=41 Participants
|
27.0 Years
STANDARD_DEVIATION 7.00 • n=35 Participants
|
26.3 Years
STANDARD_DEVIATION 6.48 • n=31 Participants
|
28.0 Years
STANDARD_DEVIATION 7.27 • n=146 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
24 Participants
n=35 Participants
|
24 Participants
n=31 Participants
|
72 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Asian-Japanese Heritage
|
12 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
24 Participants
n=35 Participants
|
24 Participants
n=31 Participants
|
72 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dosePopulation: Pharmacokinetic (PK) Population is defined as all participants who were administered at least one dose of study treatment and blood samples for plasma drug concentration were taken and analyzed.
Blood samples were collected to measure AUC(0-t) at indicated time-points. AUC(0-t) was calculated by the linear trapezoidal method (i.e., Linear Trapezoidal Linear Interpolation calculation method in Phoenix WinNonlin).
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 1: Area Under the Concentration-time Curve (AUC) From Time Zero Time (Pre-dose) to the Time of Last Quantifiable Concentration (AUC[0-t]) of Levocetirizine
|
1803.2 Hours*nanogram per milliliter (Hr*ng/mL)
Interval 1678.8 to 1936.8
|
1758.5 Hours*nanogram per milliliter (Hr*ng/mL)
Interval 1616.5 to 1913.0
|
PRIMARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected to measure AUC(0-t) at indicated time-points. AUC(0-t) was calculated by the linear trapezoidal method (i.e., Linear Trapezoidal Linear Interpolation calculation method in Phoenix WinNonlin).
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=47 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=48 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 2: AUC(0-t) of Levocetirizine
|
1843.5 Hr*ng/mL
Interval 1748.3 to 1943.9
|
1809.9 Hr*ng/mL
Interval 1715.8 to 1909.2
|
PRIMARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dosePopulation: PK Population
Blood samples were collected at indicated time points for analysis of Cmax. The values for Cmax were obtained directly from the concentration-time data.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 1: Maximum Observed Concentration (Cmax) of Levocetirizine
|
235.4 Nanogram per milliliter (ng/mL)
Interval 214.2 to 258.7
|
219.9 Nanogram per milliliter (ng/mL)
Interval 202.2 to 239.2
|
PRIMARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points for analysis of Cmax. The values for Cmax were obtained directly from the concentration-time data.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=47 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=48 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 2: Cmax of Levocetirizine
|
223.6 ng/mL
Interval 207.8 to 240.5
|
191.5 ng/mL
Interval 181.8 to 201.8
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dosePopulation: PK Population
Blood samples were collected at indicated time points for analysis of AUC(0-inf). AUC(0-inf)) of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 1: Area Under the Concentration-time Curve From Zero Time (Pre-dose) Extrapolated to Infinite Time AUC(0-inf) of Levocetirizine
|
1852.5 Hr*ng/mL
Interval 1721.0 to 1994.0
|
1812.9 Hr*ng/mL
Interval 1662.9 to 1976.3
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points for analysis of AUC(0-inf). AUC(0-inf) of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=47 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=48 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 2: AUC(0-inf) of Levocetirizine
|
1900.2 Hr*ng/mL
Interval 1798.1 to 2008.2
|
1869.5 Hr*ng/mL
Interval 1768.7 to 1976.0
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dosePopulation: PK Population
Blood samples were collected at indicated time points for analysis of tmax. The tmax of levocetirizine was obtained directly from the concentration-time data. The tmax was analyzed with the non-parametric Wilcoxon Matched Pairs Method (Signed Rank Method) to compute point estimate and associated 90% confidence interval for the median difference.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 1: Time to First Occurrence of Cmax (Tmax) of Levocetirizine
|
0.7500 Hours
Interval 0.5 to 1.5
|
0.5000 Hours
Interval 0.5 to 1.5
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points for analysis of tmax. The tmax of levocetirizine was obtained directly from the concentration-time data. The tmax was analyzed with the non-parametric Wilcoxon Matched Pairs Method (Signed Rank Method) to compute point estimate and associated 90% confidence interval for the median difference.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=47 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=48 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 2: Tmax of Levocetirizine
|
1.0000 Hours
Interval 0.5 to 3.0
|
1.0000 Hours
Interval 0.5 to 4.0
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dosePopulation: PK Population
Blood samples were collected at indicated time points for analysis of t1/2. The t1/2 of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 1: Apparent Terminal Phase Half-life (t1/2) of Levocetirizine
|
8.544 Hours
Interval 7.945 to 9.187
|
8.784 Hours
Interval 8.143 to 9.475
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points for analysis of t1/2. The t1/2 of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=47 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=48 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 2: t1/2 of Levocetirizine
|
8.933 Hours
Interval 8.545 to 9.338
|
9.024 Hours
Interval 8.611 to 9.458
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dosePopulation: PK Population
Blood samples were collected at indicated time points for analysis of %AUCex. Percentage AUCex of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 1: Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex) of Levocetirizine
|
2.500 Percentage AUCex
Interval 2.156 to 2.898
|
2.772 Percentage AUCex
Interval 2.354 to 3.264
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points for analysis of %AUCex. Percentage AUCex of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=47 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=48 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 2: %AUCex of Levocetirizine
|
2.779 Percentage AUCex
Interval 2.501 to 3.089
|
2.973 Percentage AUCex
Interval 2.678 to 3.301
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dosePopulation: PK Population
Blood samples were collected at indicated time points for analysis of CL/F. CL/F of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 1: Apparent Clearance Following Oral Dosing (CL/F) of Levocetirizine
|
2.699 Liters per hour
Interval 2.507 to 2.905
|
2.758 Liters per hour
Interval 2.53 to 3.007
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points for analysis of CL/F. CL/F of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=47 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=48 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 2: CL/F of Levocetirizine
|
2.631 Liters per hour
Interval 2.49 to 2.781
|
2.675 Liters per hour
Interval 2.53 to 2.827
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dosePopulation: PK Population
Blood samples were collected at indicated time points for analysis of Vz/F. Vz/F of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 1: Apparent Volume of Distribution Following Oral Dosing (Vz/F) of Levocetirizine
|
33.27 Liters
Interval 31.55 to 35.08
|
34.95 Liters
Interval 33.0 to 37.02
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points for analysis of Vz/F. Vz/F of levocetirizine was calculated as by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=47 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=48 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 2: Vz/F of Levocetirizine
|
33.91 Liters
Interval 32.6 to 35.27
|
34.82 Liters
Interval 33.54 to 36.14
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dosePopulation: PK Population
Blood samples were collected at indicated time points for analysis of kel. kel (lambda\_z) is the first order rate constant associated with the terminal (log-linear) portion of the curve. kel of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 1: Elimination Rate Constant (Kel) (lambda_z) of Levocetirizine
|
0.08113 Per hour
Interval 0.07545 to 0.08724
|
0.07891 Per hour
Interval 0.07316 to 0.08512
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points for analysis of kel. kel (lambda\_z) is the first order rate constant associated with the terminal (log-linear) portion of the curve. kel of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=47 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=48 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 2: Kel (lambda_z) of Levocetirizine
|
0.07760 Per hour
Interval 0.07422 to 0.08112
|
0.07681 Per hour
Interval 0.07329 to 0.0805
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dosePopulation: PK Population
Blood samples were collected at indicated time points for analysis of MRT. MRT of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 1: Mean Residence Time (MRT) of Levocetirizine
|
11.417 Hours
Interval 10.629 to 12.265
|
11.545 Hours
Interval 10.649 to 12.516
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points for analysis of MRT. MRT of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=47 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=48 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 2: MRT of Levocetirizine
|
12.272 Hours
Interval 11.727 to 12.841
|
12.573 Hours
Interval 11.991 to 13.182
|
SECONDARY outcome
Timeframe: Up to 18 daysPopulation: Safety Population consists of all participants who were administered at least one dose of study treatment.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any untoward medical occurrence that, at any dose may results in death or is life-threatening or requires inpatient hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 18 daysPopulation: Safety Population. Only those participants with data available at the specified data points were analyzed.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any untoward medical occurrence that, at any dose may results in death or is life-threatening or requires inpatient hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=47 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=48 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 2: Number of Participants With AEs and SAEs
AEs
|
0 Participants
|
6 Participants
|
|
Part 2: Number of Participants With AEs and SAEs
SAEs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dosePopulation: Safety Population.
Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in albumin and total protein levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 1: Change From Baseline in Albumin and Total Protein Levels
Albumin
|
1.5 Grams per liter (g/L)
Standard Deviation 1.59
|
1.6 Grams per liter (g/L)
Standard Deviation 1.64
|
|
Part 1: Change From Baseline in Albumin and Total Protein Levels
Total protein
|
2.3 Grams per liter (g/L)
Standard Deviation 2.26
|
2.7 Grams per liter (g/L)
Standard Deviation 2.16
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dosePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in albumin and total protein levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=47 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=48 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 2: Change From Baseline in Albumin and Total Protein Levels
Albumin
|
1.4 g/L
Standard Deviation 2.17
|
1.2 g/L
Standard Deviation 2.08
|
|
Part 2: Change From Baseline in Albumin and Total Protein Levels
Total protein
|
1.9 g/L
Standard Deviation 3.34
|
1.8 g/L
Standard Deviation 3.02
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dosePopulation: Safety Population.
Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase, gamma glutamyl transferase and lactate dehydrogenase levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 1: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels
Alkaline phosphatase
|
-1.6 International units per liter (IU/L)
Standard Deviation 7.81
|
-0.8 International units per liter (IU/L)
Standard Deviation 8.08
|
|
Part 1: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels
Alanine amino transferase
|
1.0 International units per liter (IU/L)
Standard Deviation 3.32
|
0.5 International units per liter (IU/L)
Standard Deviation 3.51
|
|
Part 1: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels
Aspartate amino transferase
|
-0.3 International units per liter (IU/L)
Standard Deviation 2.05
|
-0.1 International units per liter (IU/L)
Standard Deviation 2.81
|
|
Part 1: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels
Creatine kinase
|
-13.2 International units per liter (IU/L)
Standard Deviation 11.77
|
-10.0 International units per liter (IU/L)
Standard Deviation 29.62
|
|
Part 1: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels
Gamma glutamyl transferase
|
-0.5 International units per liter (IU/L)
Standard Deviation 1.82
|
-0.6 International units per liter (IU/L)
Standard Deviation 1.06
|
|
Part 1: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels
Lactate dehydrogenase
|
-8.8 International units per liter (IU/L)
Standard Deviation 10.10
|
-11.0 International units per liter (IU/L)
Standard Deviation 21.05
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dosePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase, gamma glutamyl transferase and lactate dehydrogenase levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=47 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=48 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 2: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels
Alkaline phosphatase
|
-2.3 IU/L
Standard Deviation 14.17
|
-1.1 IU/L
Standard Deviation 13.46
|
|
Part 2: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels
Alanine amino transferase
|
-0.7 IU/L
Standard Deviation 2.63
|
-0.5 IU/L
Standard Deviation 2.05
|
|
Part 2: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels
Aspartate amino transferase
|
-0.1 IU/L
Standard Deviation 2.58
|
0.1 IU/L
Standard Deviation 1.65
|
|
Part 2: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels
Creatine kinase
|
-16.3 IU/L
Standard Deviation 20.93
|
-12.4 IU/L
Standard Deviation 16.24
|
|
Part 2: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels
Gamma glutamyl transferase
|
-0.1 IU/L
Standard Deviation 1.52
|
-0.1 IU/L
Standard Deviation 1.28
|
|
Part 2: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels
Lactate dehydrogenase
|
-3.7 IU/L
Standard Deviation 11.55
|
-3.5 IU/L
Standard Deviation 10.52
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dosePopulation: Safety Population.
Blood samples were collected for the assessment of clinical chemistry parameters. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 1: Change From Baseline in Amylase Levels
|
7.2 Units per liter (U/L)
Standard Deviation 10.62
|
6.3 Units per liter (U/L)
Standard Deviation 7.94
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dosePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in amylase levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=47 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=48 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 2: Change From Baseline in Amylase Levels
|
7.1 U/L
Standard Deviation 10.13
|
7.4 U/L
Standard Deviation 6.69
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dosePopulation: Safety Population.
Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in direct bilirubin, total bilirubin, creatinine and uric acid levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 1: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels
Direct bilirubin
|
0.356 Micromoles per liter (UMOL/L)
Standard Deviation 1.0059
|
0.214 Micromoles per liter (UMOL/L)
Standard Deviation 0.9178
|
|
Part 1: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels
Total bilirubin
|
-1.710 Micromoles per liter (UMOL/L)
Standard Deviation 4.0340
|
0.143 Micromoles per liter (UMOL/L)
Standard Deviation 3.3034
|
|
Part 1: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels
Creatinine
|
-1.9890 Micromoles per liter (UMOL/L)
Standard Deviation 4.09064
|
-1.9522 Micromoles per liter (UMOL/L)
Standard Deviation 4.20313
|
|
Part 1: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels
Uric acid
|
23.2963 Micromoles per liter (UMOL/L)
Standard Deviation 27.33699
|
21.0658 Micromoles per liter (UMOL/L)
Standard Deviation 22.25394
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dosePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in direct bilirubin, total bilirubin, creatinine and uric acid levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=47 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=48 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 2: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels
Direct bilirubin
|
0.036 UMOL/L
Standard Deviation 0.7555
|
-0.071 UMOL/L
Standard Deviation 0.7018
|
|
Part 2: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels
Total bilirubin
|
-0.619 UMOL/L
Standard Deviation 3.1374
|
-0.748 UMOL/L
Standard Deviation 3.0325
|
|
Part 2: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels
Creatinine
|
-3.8746 UMOL/L
Standard Deviation 5.00254
|
-3.5913 UMOL/L
Standard Deviation 4.21949
|
|
Part 2: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels
Uric acid
|
13.6677 UMOL/L
Standard Deviation 28.30678
|
14.0026 UMOL/L
Standard Deviation 20.14225
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dosePopulation: Safety Population.
Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in calcium, cholesterol, chloride, glucose, high density lipids cholesterol, potassium, low density lipids cholesterol, sodium, phosphorus inorganic, triglycerides and urea/blood urea nitrogen (BUN) levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels
Phosphorus inorganic
|
-0.182977 Millimoles per liter (MMOL/L)
Standard Deviation 0.0849880
|
-0.193740 Millimoles per liter (MMOL/L)
Standard Deviation 0.0737556
|
|
Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels
Calcium
|
0.018713 Millimoles per liter (MMOL/L)
Standard Deviation 0.0594308
|
0.032227 Millimoles per liter (MMOL/L)
Standard Deviation 0.0490682
|
|
Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels
Cholesterol
|
0.054953 Millimoles per liter (MMOL/L)
Standard Deviation 0.2589722
|
0.117448 Millimoles per liter (MMOL/L)
Standard Deviation 0.2967150
|
|
Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels
Chloride
|
-1.0 Millimoles per liter (MMOL/L)
Standard Deviation 1.43
|
-0.9 Millimoles per liter (MMOL/L)
Standard Deviation 1.19
|
|
Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels
Glucose
|
-0.050884 Millimoles per liter (MMOL/L)
Standard Deviation 0.2037377
|
-0.067075 Millimoles per liter (MMOL/L)
Standard Deviation 0.2724243
|
|
Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels
High density lipids cholesterol
|
-0.063573 Millimoles per liter (MMOL/L)
Standard Deviation 0.0806953
|
-0.032325 Millimoles per liter (MMOL/L)
Standard Deviation 0.1006621
|
|
Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels
Potassium
|
0.10 Millimoles per liter (MMOL/L)
Standard Deviation 0.330
|
0.13 Millimoles per liter (MMOL/L)
Standard Deviation 0.311
|
|
Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels
Low density lipids cholesterol
|
0.038790 Millimoles per liter (MMOL/L)
Standard Deviation 0.2158221
|
0.059263 Millimoles per liter (MMOL/L)
Standard Deviation 0.2661881
|
|
Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels
Sodium
|
-0.7 Millimoles per liter (MMOL/L)
Standard Deviation 1.49
|
-0.6 Millimoles per liter (MMOL/L)
Standard Deviation 1.24
|
|
Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels
Triglycerides
|
-0.00047 Millimoles per liter (MMOL/L)
Standard Deviation 0.304261
|
0.04520 Millimoles per liter (MMOL/L)
Standard Deviation 0.284839
|
|
Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels
Urea/BUN
|
0.08033 Millimoles per liter (MMOL/L)
Standard Deviation 0.498940
|
0.01934 Millimoles per liter (MMOL/L)
Standard Deviation 0.472088
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dosePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in calcium, cholesterol, chloride, glucose, high density lipids cholesterol, potassium, low density lipids cholesterol, sodium, phosphorus inorganic, triglycerides and urea/BUN levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=47 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=48 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels
Calcium
|
0.015926 MMOL/L
Standard Deviation 0.0704590
|
0.015594 MMOL/L
Standard Deviation 0.0623219
|
|
Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels
Cholesterol
|
0.064925 MMOL/L
Standard Deviation 0.2594347
|
0.083506 MMOL/L
Standard Deviation 0.2666316
|
|
Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels
Chloride
|
-0.5 MMOL/L
Standard Deviation 1.35
|
-0.6 MMOL/L
Standard Deviation 1.17
|
|
Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels
Glucose
|
0.059053 MMOL/L
Standard Deviation 0.2990211
|
-0.049728 MMOL/L
Standard Deviation 0.2525006
|
|
Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels
High density lipids cholesterol
|
-0.047869 MMOL/L
Standard Deviation 0.0975044
|
-0.049565 MMOL/L
Standard Deviation 0.1151357
|
|
Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels
Potassium
|
0.08 MMOL/L
Standard Deviation 0.368
|
-0.03 MMOL/L
Standard Deviation 0.233
|
|
Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels
Low density lipids cholesterol
|
0.084733 MMOL/L
Standard Deviation 0.1846539
|
0.123374 MMOL/L
Standard Deviation 0.1986158
|
|
Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels
Sodium
|
-0.6 MMOL/L
Standard Deviation 1.05
|
-1.1 MMOL/L
Standard Deviation 1.28
|
|
Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels
Phosphorus inorganic
|
-0.239770 MMOL/L
Standard Deviation 0.1230018
|
-0.203831 MMOL/L
Standard Deviation 0.1251750
|
|
Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels
Triglycerides
|
0.03606 MMOL/L
Standard Deviation 0.206604
|
-0.02707 MMOL/L
Standard Deviation 0.290907
|
|
Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels
Urea/BUN
|
-0.45802 MMOL/L
Standard Deviation 0.817628
|
-0.12272 MMOL/L
Standard Deviation 0.622969
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dosePopulation: Safety Population.
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes and total neutrophils levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 1: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count
Basophils
|
0.01 Percentage
Standard Deviation 0.212
|
-0.01 Percentage
Standard Deviation 0.150
|
|
Part 1: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count
Eosinophils
|
-0.52 Percentage
Standard Deviation 1.087
|
-0.53 Percentage
Standard Deviation 0.783
|
|
Part 1: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count
Lymphocytes
|
-5.96 Percentage
Standard Deviation 7.705
|
-5.94 Percentage
Standard Deviation 6.330
|
|
Part 1: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count
Monocytes
|
0.16 Percentage
Standard Deviation 1.443
|
-0.16 Percentage
Standard Deviation 0.835
|
|
Part 1: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count
Total neutrophils levels
|
6.32 Percentage
Standard Deviation 7.950
|
6.64 Percentage
Standard Deviation 6.480
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dosePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes and total neutrophils levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=47 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=48 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 2: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count
Basophils
|
0.04 Percentage
Standard Deviation 0.176
|
0.08 Percentage
Standard Deviation 0.195
|
|
Part 2: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count
Eosinophils
|
-0.74 Percentage
Standard Deviation 1.012
|
-0.92 Percentage
Standard Deviation 1.183
|
|
Part 2: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count
Lymphocytes
|
-8.07 Percentage
Standard Deviation 5.558
|
-8.45 Percentage
Standard Deviation 6.915
|
|
Part 2: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count
Monocytes
|
-0.48 Percentage
Standard Deviation 1.087
|
-0.49 Percentage
Standard Deviation 1.046
|
|
Part 2: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count
Total neutrophils levels
|
9.25 Percentage
Standard Deviation 5.847
|
9.78 Percentage
Standard Deviation 7.094
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dosePopulation: Safety Population.
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in platelet count and white blood cell count were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 1: Change From Baseline in Platelet Count and White Blood Cell Count
Platelet count
|
-11.4 Giga per liter (GI/L)
Standard Deviation 11.64
|
-6.4 Giga per liter (GI/L)
Standard Deviation 12.62
|
|
Part 1: Change From Baseline in Platelet Count and White Blood Cell Count
White blood cell count
|
-1.26 Giga per liter (GI/L)
Standard Deviation 0.596
|
-0.94 Giga per liter (GI/L)
Standard Deviation 0.950
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dosePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in platelet count and white blood cell count were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=47 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=48 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 2: Change From Baseline in Platelet Count and White Blood Cell Count
Platelet count
|
-2.9 GI/L
Standard Deviation 13.98
|
-2.5 GI/L
Standard Deviation 12.71
|
|
Part 2: Change From Baseline in Platelet Count and White Blood Cell Count
White blood cell count
|
-1.06 GI/L
Standard Deviation 1.133
|
-1.14 GI/L
Standard Deviation 1.246
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dosePopulation: Safety Population.
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hemoglobin and mean corpuscle hemoglobin concentration were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 1: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration
Hemoglobin
|
2.3 Grams per liter (G/L)
Standard Deviation 3.44
|
2.2 Grams per liter (G/L)
Standard Deviation 3.81
|
|
Part 1: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration
Mean corpuscle hemoglobin concentration
|
1.8 Grams per liter (G/L)
Standard Deviation 4.64
|
2.3 Grams per liter (G/L)
Standard Deviation 4.16
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dosePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hemoglobin and mean corpuscle hemoglobin concentration were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=47 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=48 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 2: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration
Hemoglobin
|
0.9 G/L
Standard Deviation 5.69
|
0.9 G/L
Standard Deviation 4.87
|
|
Part 2: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration
Mean corpuscle hemoglobin concentration
|
0.5 G/L
Standard Deviation 3.87
|
0.2 G/L
Standard Deviation 4.12
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dosePopulation: Safety Population.
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hematocrit was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 1: Change Form Baseline in Hematocrit
|
0.0043 Proportion of red blood cells in blood
Standard Deviation 0.00952
|
0.0036 Proportion of red blood cells in blood
Standard Deviation 0.01014
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dosePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hematocrit was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=47 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=48 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 2: Change Form Baseline in Hematocrit
|
0.0019 Proportion of red blood cells in blood
Standard Deviation 0.01595
|
0.0023 Proportion of red blood cells in blood
Standard Deviation 0.01505
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dosePopulation: Safety Population.
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle hemoglobin was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 1: Change From Baseline in Mean Corpuscle Hemoglobin
|
-0.03 Picograms
Standard Deviation 0.288
|
-0.04 Picograms
Standard Deviation 0.313
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dosePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle hemoglobin was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=47 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=48 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 2: Change From Baseline in Mean Corpuscle Hemoglobin
|
-0.07 Picograms
Standard Deviation 0.265
|
-0.07 Picograms
Standard Deviation 0.305
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dosePopulation: Safety Population.
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle volume was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 1: Change From Baseline in Mean Corpuscle Volume
|
-0.5 Femtoliters
Standard Deviation 0.83
|
-0.6 Femtoliters
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dosePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle volume was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=47 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=48 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 2: Change From Baseline in Mean Corpuscle Volume
|
-0.3 Femtoliters
Standard Deviation 0.63
|
-0.2 Femtoliters
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dosePopulation: Safety Population.
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in red blood cell count was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 1: Change From Baseline in Red Blood Cell Count
|
0.080 Trillion cells per liter
Standard Deviation 0.1235
|
0.078 Trillion cells per liter
Standard Deviation 0.1189
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dosePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in red blood cell count was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=47 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=48 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 2: Change From Baseline in Red Blood Cell Count
|
0.041 Trillion cells per liter
Standard Deviation 0.1883
|
0.040 Trillion cells per liter
Standard Deviation 0.1730
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dosePopulation: Safety Population.
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in reticulocytes was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 1: Change From Baseline in Reticulocytes
|
0.0004 Percentage of reticulocytes
Standard Deviation 0.00186
|
-0.0001 Percentage of reticulocytes
Standard Deviation 0.00167
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dosePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in reticulocytes was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=47 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=48 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 2: Change From Baseline in Reticulocytes
|
-0.0004 Percentage of reticulocytes
Standard Deviation 0.00169
|
-0.0001 Percentage of reticulocytes
Standard Deviation 0.00173
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1) and 48 hours post-dosePopulation: Safety Population.
Urine samples were collected to assess urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen by dipstick test. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen can be read as negative (-), trace and 1+ indicating proportional concentrations in the urine sample. Only categories with significant values have been presented.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 1: Number of Participants With Urinalysis Results by Dipstick Method
Bilirubin, Pre-dose, negative
|
24 Participants
|
24 Participants
|
|
Part 1: Number of Participants With Urinalysis Results by Dipstick Method
Bilirubin, 48 hours, negative
|
24 Participants
|
24 Participants
|
|
Part 1: Number of Participants With Urinalysis Results by Dipstick Method
Occult blood, Pre-dose, negative
|
24 Participants
|
23 Participants
|
|
Part 1: Number of Participants With Urinalysis Results by Dipstick Method
Occult blood, Pre-dose, trace
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Urinalysis Results by Dipstick Method
Occult blood, 48 hours, negative
|
24 Participants
|
23 Participants
|
|
Part 1: Number of Participants With Urinalysis Results by Dipstick Method
Occult blood, 48 hours, trace
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Urinalysis Results by Dipstick Method
Glucose, Pre-dose, negative
|
24 Participants
|
24 Participants
|
|
Part 1: Number of Participants With Urinalysis Results by Dipstick Method
Glucose, 48 hours, negative
|
24 Participants
|
24 Participants
|
|
Part 1: Number of Participants With Urinalysis Results by Dipstick Method
Ketones, Pre-dose, negative
|
23 Participants
|
24 Participants
|
|
Part 1: Number of Participants With Urinalysis Results by Dipstick Method
Ketones, Pre-dose, positive (1+)
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Urinalysis Results by Dipstick Method
Ketones, 48 hours, negative
|
24 Participants
|
24 Participants
|
|
Part 1: Number of Participants With Urinalysis Results by Dipstick Method
Protein, Pre-dose, negative
|
24 Participants
|
24 Participants
|
|
Part 1: Number of Participants With Urinalysis Results by Dipstick Method
Protein, 48 hours, negative
|
24 Participants
|
24 Participants
|
|
Part 1: Number of Participants With Urinalysis Results by Dipstick Method
Urobilinogen, Pre-dose, trace
|
24 Participants
|
24 Participants
|
|
Part 1: Number of Participants With Urinalysis Results by Dipstick Method
Urobilinogen, 48 hours, trace
|
24 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1) and 48 hours post-dosePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed.
Urine samples were collected to assess urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen by dipstick test. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen can be read as negative (-), trace and 1+ indicating proportional concentrations in the urine sample. Only categories with significant values have been presented.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=47 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=48 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 2: Number of Participants With Urinalysis Results by Dipstick Method
Bilirubin, Pre-dose, negative
|
47 Participants
|
48 Participants
|
|
Part 2: Number of Participants With Urinalysis Results by Dipstick Method
Bilirubin, 48 hours, negative
|
47 Participants
|
48 Participants
|
|
Part 2: Number of Participants With Urinalysis Results by Dipstick Method
Occult blood, Pre-dose, negative
|
47 Participants
|
48 Participants
|
|
Part 2: Number of Participants With Urinalysis Results by Dipstick Method
Occult blood, 48 hours, negative
|
47 Participants
|
47 Participants
|
|
Part 2: Number of Participants With Urinalysis Results by Dipstick Method
Occult blood, 48 hours, trace
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Urinalysis Results by Dipstick Method
Glucose, Pre-dose, negative
|
47 Participants
|
48 Participants
|
|
Part 2: Number of Participants With Urinalysis Results by Dipstick Method
Glucose, 48 hours, negative
|
47 Participants
|
48 Participants
|
|
Part 2: Number of Participants With Urinalysis Results by Dipstick Method
Ketones, Pre-dose, negative
|
46 Participants
|
48 Participants
|
|
Part 2: Number of Participants With Urinalysis Results by Dipstick Method
Ketones, Pre-dose, positive (1+)
|
1 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Urinalysis Results by Dipstick Method
Ketones, 48 hours, negative
|
47 Participants
|
48 Participants
|
|
Part 2: Number of Participants With Urinalysis Results by Dipstick Method
Protein, Pre-dose, negative
|
47 Participants
|
48 Participants
|
|
Part 2: Number of Participants With Urinalysis Results by Dipstick Method
Protein, 48 hours, negative
|
47 Participants
|
48 Participants
|
|
Part 2: Number of Participants With Urinalysis Results by Dipstick Method
Urobilinogen, Pre-dose, trace
|
47 Participants
|
48 Participants
|
|
Part 2: Number of Participants With Urinalysis Results by Dipstick Method
Urobilinogen, 48 hours, trace
|
47 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1) and 48 hours post-dosePopulation: Safety Population.
Urine samples were collected for the measurement of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 1: Urine Potential of Hydrogen (pH)
Pre-dose
|
6.06 pH
Standard Deviation 0.340
|
6.04 pH
Standard Deviation 0.359
|
|
Part 1: Urine Potential of Hydrogen (pH)
48 hours
|
6.02 pH
Standard Deviation 0.275
|
6.10 pH
Standard Deviation 0.329
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1) and 48 hours post-dosePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed.
Urine samples were collected for the measurement of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=47 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=48 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 2: Urine Potential of Hydrogen (pH)
Pre-dose
|
6.11 pH
Standard Deviation 0.345
|
6.20 pH
Standard Deviation 0.353
|
|
Part 2: Urine Potential of Hydrogen (pH)
48 hours
|
6.00 pH
Standard Deviation 0.376
|
6.09 pH
Standard Deviation 0.395
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1) and 48 hours post-dosePopulation: Safety Population.
Urine samples were collected for the measurement of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. The urinary specific gravity measurement is a routine part of urinalysis. The reference range is 1.002-1.030.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 1: Urine Specific Gravity
Pre-dose
|
1.0144 Ratio
Standard Deviation 0.00658
|
1.0158 Ratio
Standard Deviation 0.00724
|
|
Part 1: Urine Specific Gravity
48 hours
|
1.0163 Ratio
Standard Deviation 0.00798
|
1.0178 Ratio
Standard Deviation 0.00751
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1) and 48 hours post-dosePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed.
Urine samples were collected for the measurement of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. The urinary specific gravity measurement is a routine part of urinalysis. The reference range is 1.002-1.030.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=47 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=48 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 2: Urine Specific Gravity
Pre-dose
|
1.0179 Ratio
Standard Deviation 0.00666
|
1.0156 Ratio
Standard Deviation 0.00646
|
|
Part 2: Urine Specific Gravity
48 hours
|
1.0159 Ratio
Standard Deviation 0.00749
|
1.0160 Ratio
Standard Deviation 0.00669
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dosePopulation: Safety Population.
Blood pressure was measured in supine position after 5 minutes rest. Change from Baseline in SBP and DBP was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, 24 hour
|
0.6 Millimeters of mercury (mmHg)
Standard Deviation 7.20
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation 7.23
|
|
Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, 1 hour
|
0.4 Millimeters of mercury (mmHg)
Standard Deviation 8.54
|
-2.0 Millimeters of mercury (mmHg)
Standard Deviation 9.68
|
|
Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, 48 hour
|
1.3 Millimeters of mercury (mmHg)
Standard Deviation 7.51
|
-1.2 Millimeters of mercury (mmHg)
Standard Deviation 9.64
|
|
Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, 1 hour
|
-2.2 Millimeters of mercury (mmHg)
Standard Deviation 6.84
|
-1.8 Millimeters of mercury (mmHg)
Standard Deviation 5.67
|
|
Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, 24 hour
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation 6.19
|
0.3 Millimeters of mercury (mmHg)
Standard Deviation 4.47
|
|
Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, 48 hour
|
1.1 Millimeters of mercury (mmHg)
Standard Deviation 6.10
|
0.6 Millimeters of mercury (mmHg)
Standard Deviation 6.98
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dosePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed.
Blood pressure was measured in supine position after 5 minutes rest. Change from Baseline in SBP and DBP was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=47 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=48 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 2: Change From Baseline in SBP and DBP
DBP, 1 hour
|
-2.6 mmHg
Standard Deviation 6.35
|
-2.6 mmHg
Standard Deviation 7.07
|
|
Part 2: Change From Baseline in SBP and DBP
DBP, 24 hour
|
-1.2 mmHg
Standard Deviation 6.23
|
-2.3 mmHg
Standard Deviation 6.11
|
|
Part 2: Change From Baseline in SBP and DBP
SBP, 1 hour
|
-0.9 mmHg
Standard Deviation 8.27
|
0.2 mmHg
Standard Deviation 9.22
|
|
Part 2: Change From Baseline in SBP and DBP
SBP, 24 hour
|
-1.2 mmHg
Standard Deviation 9.16
|
-1.9 mmHg
Standard Deviation 7.69
|
|
Part 2: Change From Baseline in SBP and DBP
SBP, 48 hour
|
0.3 mmHg
Standard Deviation 9.15
|
0.7 mmHg
Standard Deviation 9.95
|
|
Part 2: Change From Baseline in SBP and DBP
DBP, 48 hour
|
-0.2 mmHg
Standard Deviation 6.22
|
-0.6 mmHg
Standard Deviation 7.15
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dosePopulation: Safety Population.
Heart rate was measured in supine position after 5 minutes rest. Change from Baseline in heart rate was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 1: Change From Baseline in Heart Rate
1 hour
|
-0.9 Beats per minute
Standard Deviation 4.62
|
-2.3 Beats per minute
Standard Deviation 4.77
|
|
Part 1: Change From Baseline in Heart Rate
24 hour
|
-0.1 Beats per minute
Standard Deviation 5.50
|
-0.8 Beats per minute
Standard Deviation 5.24
|
|
Part 1: Change From Baseline in Heart Rate
48 hour
|
2.5 Beats per minute
Standard Deviation 5.90
|
0.8 Beats per minute
Standard Deviation 6.13
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dosePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed.
Heart rate was measured in supine position after 5 minutes rest. Change from Baseline in heart rate was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=47 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=48 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 2: Change From Baseline in Heart Rate
48 hour
|
3.0 Beats per minute
Standard Deviation 9.08
|
1.5 Beats per minute
Standard Deviation 10.85
|
|
Part 2: Change From Baseline in Heart Rate
1 hour
|
-0.6 Beats per minute
Standard Deviation 5.24
|
-1.5 Beats per minute
Standard Deviation 8.34
|
|
Part 2: Change From Baseline in Heart Rate
24 hour
|
0.6 Beats per minute
Standard Deviation 6.91
|
-1.9 Beats per minute
Standard Deviation 9.16
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dosePopulation: Safety Population.
Body temperature was measured in supine position after 5 minutes rest. Change from Baseline in body temperature was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 1: Change From Baseline in Body Temperature
1 hour
|
0.02 Degree Celsius
Standard Deviation 0.392
|
0.20 Degree Celsius
Standard Deviation 0.313
|
|
Part 1: Change From Baseline in Body Temperature
24 hour
|
0.09 Degree Celsius
Standard Deviation 0.268
|
-0.01 Degree Celsius
Standard Deviation 0.292
|
|
Part 1: Change From Baseline in Body Temperature
48 hour
|
0.01 Degree Celsius
Standard Deviation 0.307
|
0.06 Degree Celsius
Standard Deviation 0.280
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dosePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed.
Body temperature was measured in supine position after 5 minutes rest. Change from Baseline in body temperature was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=47 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=48 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 2: Change From Baseline in Body Temperature
1 hour
|
0.09 Degree Celsius
Standard Deviation 0.359
|
0.19 Degree Celsius
Standard Deviation 0.362
|
|
Part 2: Change From Baseline in Body Temperature
24 hour
|
0.08 Degree Celsius
Standard Deviation 0.324
|
0.13 Degree Celsius
Standard Deviation 0.272
|
|
Part 2: Change From Baseline in Body Temperature
48 hour
|
0.03 Degree Celsius
Standard Deviation 0.345
|
0.03 Degree Celsius
Standard Deviation 0.351
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 1, 48 hours post-dosePopulation: Safety Population.
Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval with Fridericia's correction (QTcF). Change from Baseline in heart rate (ECG) was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 1: Change From Baseline in Heart Rate (12-Lead Electrocardiogram [ECG])
1 hour
|
1.0 Beats per minute
Standard Deviation 4.47
|
1.6 Beats per minute
Standard Deviation 4.80
|
|
Part 1: Change From Baseline in Heart Rate (12-Lead Electrocardiogram [ECG])
48 hour
|
2.5 Beats per minute
Standard Deviation 4.74
|
2.1 Beats per minute
Standard Deviation 4.37
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 1, 48 hours post-dosePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed.
Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF. Change from Baseline in heart rate (ECG) was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=47 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=48 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 2: Change From Baseline in Heart Rate (ECG)
1 hour
|
-1.7 Beats per minute
Standard Deviation 5.83
|
-1.0 Beats per minute
Standard Deviation 5.72
|
|
Part 2: Change From Baseline in Heart Rate (ECG)
48 hour
|
1.9 Beats per minute
Standard Deviation 8.05
|
1.7 Beats per minute
Standard Deviation 8.22
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 1, 48 hours post-dosePopulation: Safety Population.
Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF. Change from Baseline in PR interval, QRS interval, QT interval and QTcF interval was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=24 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval
PR interval, 1 hour
|
-6.3 Millisecond
Standard Deviation 10.00
|
-7.3 Millisecond
Standard Deviation 12.16
|
|
Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval
PR interval, 48 hour
|
-1.9 Millisecond
Standard Deviation 13.03
|
-5.5 Millisecond
Standard Deviation 10.72
|
|
Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval
QRS duration, 1 hour
|
-0.8 Millisecond
Standard Deviation 5.24
|
-0.5 Millisecond
Standard Deviation 3.40
|
|
Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval
QRS duration, 48 hour
|
-0.6 Millisecond
Standard Deviation 6.37
|
1.7 Millisecond
Standard Deviation 3.67
|
|
Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval
QT interval, 1 hour
|
-6.4 Millisecond
Standard Deviation 15.38
|
-9.3 Millisecond
Standard Deviation 17.30
|
|
Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval
QT interval, 48 hour
|
-10.7 Millisecond
Standard Deviation 18.17
|
-14.3 Millisecond
Standard Deviation 16.00
|
|
Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval
QTcF interval, 1 hour
|
-4.3 Millisecond
Standard Deviation 11.52
|
-6.1 Millisecond
Standard Deviation 14.06
|
|
Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval
QTcF interval, 48 hour
|
-4.8 Millisecond
Standard Deviation 17.96
|
-9.3 Millisecond
Standard Deviation 14.67
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and 1, 48 hours post-dosePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed.
Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF. Change from Baseline in PR interval, QRS interval, QT interval and QTcF interval was evaluated. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Part 2: Levocetirizine IRT 5 mg
n=47 Participants
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine ODT 5 mg
n=48 Participants
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|
|
Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval
QT interval, 1 hour
|
3.1 Millisecond
Standard Deviation 18.94
|
3.8 Millisecond
Standard Deviation 14.45
|
|
Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval
PR interval, 1 hour
|
-2.8 Millisecond
Standard Deviation 8.66
|
-3.2 Millisecond
Standard Deviation 11.67
|
|
Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval
PR interval, 48 hour
|
0.6 Millisecond
Standard Deviation 9.76
|
1.2 Millisecond
Standard Deviation 11.48
|
|
Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval
QT interval, 48 hour
|
-11.4 Millisecond
Standard Deviation 20.49
|
-12.1 Millisecond
Standard Deviation 17.36
|
|
Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval
QTcF interval, 1 hour
|
-0.9 Millisecond
Standard Deviation 17.35
|
1.4 Millisecond
Standard Deviation 15.35
|
|
Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval
QTcF interval, 48 hour
|
-7.6 Millisecond
Standard Deviation 14.87
|
-8.5 Millisecond
Standard Deviation 15.75
|
|
Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval
QRS duration, 1 hour
|
-1.9 Millisecond
Standard Deviation 7.99
|
-1.4 Millisecond
Standard Deviation 5.53
|
|
Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval
QRS duration, 48 hour
|
-0.4 Millisecond
Standard Deviation 7.17
|
0.3 Millisecond
Standard Deviation 6.50
|
Adverse Events
Part 1: Levocetirizine ODT 5 mg
Part 1: Levocetirizine IRT 5 mg
Part 2: Levocetirizine ODT 5 mg
Part 2: Levocetirizine IRT 5 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1: Levocetirizine ODT 5 mg
n=24 participants at risk
All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 1: Levocetirizine IRT 5 mg
n=24 participants at risk
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 2: Levocetirizine ODT 5 mg
n=48 participants at risk
All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
Part 2: Levocetirizine IRT 5 mg
n=48 participants at risk
All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule.
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/24 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 18 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/24 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 18 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
4.2%
2/48 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 18 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/48 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 18 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/24 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 18 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/24 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 18 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
2.1%
1/48 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 18 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/48 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 18 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/24 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 18 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/24 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 18 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
2.1%
1/48 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 18 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/48 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 18 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/24 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 18 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/24 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 18 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
2.1%
1/48 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 18 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/48 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 18 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/24 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 18 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/24 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 18 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
2.1%
1/48 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 18 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/48 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 18 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/24 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 18 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/24 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 18 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
2.1%
1/48 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 18 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/48 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 18 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER