Trial Outcomes & Findings for Bioequivalence Study of Paracetamol With Oral Single Dose Administration in Healthy Adult Subjects Under Fasting Conditions (NCT NCT06855576)
NCT ID: NCT06855576
Last Updated: 2026-07-01
Results Overview
Cmax was defined as maximum observed post-dose plasma concentration for paracetamol. Blood samples were collected at indicated timepoints for the analysis of Cmax. Pharmacokinetic (PK) parameters were determined by non-compartmental analysis.
COMPLETED
PHASE1
54 participants
Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
2026-07-01
Participant Flow
This study was conducted at a single center in Germany.
A total of 54 participants were enrolled and randomized to treatment groups. A total of 52 randomized participants subsequently completed the study.
Participant milestones
| Measure |
Test Product/ Reference Product 2/ Reference Product 1
Participants were randomly assigned as per cross over design to receive oral administration of one paracetamol Orodispersable Tablet (ODT) (test product) on day 1 of period 1, one Panadol film-coated tablet (reference product 2) on day 1 of period 2 and one Alvedon film-coated tablet (reference product 1) on day 1 of period 3, each under fasting conditions. There was at least 72 hours of washout between each period (no more than 7 days).
|
Reference Product 1/ Test Product/ Reference Product 2
Participants were randomly assigned as per cross over design to receive oral administration of one Alvedon film-coated tablet (reference product 1) on day 1 of period 1, one paracetamol ODT (test product) on day 1 of period 2 and one Panadol film-coated tablet (reference product 2) on day 1 of period 3, each under fasting conditions. There was at least 72 hours of washout between each period (no more than 7 days).
|
Reference Product 2/ Reference Product 1/ Test Product
Participants were randomly assigned as per cross over design to receive oral administration of one Panadol film-coated tablet (reference product 2) on day 1 of period 1, one Alvedon film coated tablet (reference product 1) on day 1 of period 2, and one paracetamol ODT (test product) on day 1 of period 3, each under fasting conditions. There was at least 72 hours of washout between each period (no more than 7 days).
|
|---|---|---|---|
|
Treatment Period 1 (1 Day)
COMPLETED
|
18
|
18
|
18
|
|
Treatment Period 1 (1 Day)
STARTED
|
18
|
18
|
18
|
|
Treatment Period 1 (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
|
Washout Period 1 (3 Days)
STARTED
|
18
|
18
|
18
|
|
Washout Period 1 (3 Days)
COMPLETED
|
18
|
17
|
18
|
|
Washout Period 1 (3 Days)
NOT COMPLETED
|
0
|
1
|
0
|
|
Treatment Period 2 (1 Day)
STARTED
|
18
|
17
|
18
|
|
Treatment Period 2 (1 Day)
COMPLETED
|
17
|
17
|
18
|
|
Treatment Period 2 (1 Day)
NOT COMPLETED
|
1
|
0
|
0
|
|
Washout Period 2 (3 Days)
STARTED
|
17
|
17
|
18
|
|
Washout Period 2 (3 Days)
COMPLETED
|
17
|
17
|
18
|
|
Washout Period 2 (3 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Treatment Period 3 (1 Day)
STARTED
|
17
|
17
|
18
|
|
Treatment Period 3 (1 Day)
COMPLETED
|
17
|
17
|
18
|
|
Treatment Period 3 (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
|
Washout Period 3 (3 Days)
STARTED
|
17
|
17
|
18
|
|
Washout Period 3 (3 Days)
COMPLETED
|
17
|
17
|
18
|
|
Washout Period 3 (3 Days)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Test Product/ Reference Product 2/ Reference Product 1
Participants were randomly assigned as per cross over design to receive oral administration of one paracetamol Orodispersable Tablet (ODT) (test product) on day 1 of period 1, one Panadol film-coated tablet (reference product 2) on day 1 of period 2 and one Alvedon film-coated tablet (reference product 1) on day 1 of period 3, each under fasting conditions. There was at least 72 hours of washout between each period (no more than 7 days).
|
Reference Product 1/ Test Product/ Reference Product 2
Participants were randomly assigned as per cross over design to receive oral administration of one Alvedon film-coated tablet (reference product 1) on day 1 of period 1, one paracetamol ODT (test product) on day 1 of period 2 and one Panadol film-coated tablet (reference product 2) on day 1 of period 3, each under fasting conditions. There was at least 72 hours of washout between each period (no more than 7 days).
|
Reference Product 2/ Reference Product 1/ Test Product
Participants were randomly assigned as per cross over design to receive oral administration of one Panadol film-coated tablet (reference product 2) on day 1 of period 1, one Alvedon film coated tablet (reference product 1) on day 1 of period 2, and one paracetamol ODT (test product) on day 1 of period 3, each under fasting conditions. There was at least 72 hours of washout between each period (no more than 7 days).
|
|---|---|---|---|
|
Washout Period 1 (3 Days)
Withdrawal by Subject
|
0
|
1
|
0
|
|
Treatment Period 2 (1 Day)
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Overall Study Participants
n=54 Participants
Participants were randomly assigned as per cross over design to receive oral administration of one paracetamol ODT (test product), one Alvedon film-coated tablet (reference product 1) and one Panadol film-coated tablet (reference product 2) as per randomization schedule. There was at least 72 hours of washout period between each period (no more than 7 days).
|
|---|---|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 9.8 • n=54 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=54 Participants
|
PRIMARY outcome
Timeframe: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment periodPopulation: The PKAS (pharmacokinetics analysis set) was defined as all participants in the PK population who completed at least two periods with one test formulation and who had no major protocol deviations concerning pharmacokinetics. The PK population was defined as all randomised participants who had at least one measurable PK parameter. Only those participants with data available at the specified timepoint were analyzed.
Cmax was defined as maximum observed post-dose plasma concentration for paracetamol. Blood samples were collected at indicated timepoints for the analysis of Cmax. Pharmacokinetic (PK) parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Test Product
n=53 Participants
Participants were randomly assigned as per cross over design to receive oral administration of one paracetamol ODT as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
Reference Product 1
n=51 Participants
Participants were randomly assigned as per cross over design to receive oral administration of one Alvedon film-coated tablet as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
|---|---|---|
|
Maximum Observed Concentration (Cmax) for Paracetamol ODT (Test) Versus (vs.) Paracetamol (Alvedon Film-coated Tablet) (Reference 1)
|
6.27 micrograms per milliliter(µg/mL)
Geometric Coefficient of Variation 36.8
|
7.71 micrograms per milliliter(µg/mL)
Geometric Coefficient of Variation 53.6
|
PRIMARY outcome
Timeframe: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment periodPopulation: PKAS Population. Only those participants with data available at the specified timepoint were analyzed.
AUC0-tlast was defined as area under the concentration vs. time curve from dosing time to the last measurement time point with a concentration value above the lower limit of quantitation, calculated by means of the linear up/log down method (linear trapezoidal rule for increases in concentration/logarithmic trapezoidal rule for decreases in concentrations). Blood samples were collected at indicated timepoints for the analysis of AUC0-tlast. PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Test Product
n=53 Participants
Participants were randomly assigned as per cross over design to receive oral administration of one paracetamol ODT as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
Reference Product 1
n=51 Participants
Participants were randomly assigned as per cross over design to receive oral administration of one Alvedon film-coated tablet as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
|---|---|---|
|
Area Under the Concentration vs. Time Curve From Dosing Time to the Last Measurement Time Point (AUC0-tlast) for Paracetamol ODT (Test) vs. Paracetamol (Alvedon Film-coated Tablet) (Reference 1)
|
23.9 hour*microgram per milliliter (h*µg/mL)
Geometric Coefficient of Variation 36.6
|
24.3 hour*microgram per milliliter (h*µg/mL)
Geometric Coefficient of Variation 37.8
|
PRIMARY outcome
Timeframe: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment periodPopulation: PKAS Population. Only those participants with data available at the specified timepoint were analyzed.
Blood samples were collected at indicated timepoints for the analysis of tmax. PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Test Product
n=53 Participants
Participants were randomly assigned as per cross over design to receive oral administration of one paracetamol ODT as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
Reference Product 1
n=51 Participants
Participants were randomly assigned as per cross over design to receive oral administration of one Alvedon film-coated tablet as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
|---|---|---|
|
Time to Reach Maximum Concentration (Tmax) for Paracetamol ODT (Test) vs. Paracetamol (Alvedon Film-coated Tablet) (Reference 1)
|
1.00 hour(h)
Interval 0.42 to 2.0
|
0.670 hour(h)
Interval 0.25 to 2.52
|
PRIMARY outcome
Timeframe: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment periodPopulation: PKAS Population. Only those participants with data available at the specified timepoint were analyzed.
Cmax was defined as maximum observed post-dose plasma concentration for paracetamol. Blood samples were collected at indicated timepoints for the analysis of Cmax. PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Test Product
n=53 Participants
Participants were randomly assigned as per cross over design to receive oral administration of one paracetamol ODT as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
Reference Product 1
n=53 Participants
Participants were randomly assigned as per cross over design to receive oral administration of one Alvedon film-coated tablet as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
|---|---|---|
|
Cmax for Paracetamol ODT (Test) vs. Paracetamol (Panadol Film-coated Tablet) (Reference 2)
|
6.27 µg/mL
Geometric Coefficient of Variation 36.8
|
8.41 µg/mL
Geometric Coefficient of Variation 48.6
|
PRIMARY outcome
Timeframe: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment periodPopulation: PKAS Population. Only those participants with data available at the specified timepoint were analyzed.
AUC0-tlast was defined as area under the concentration vs. time curve from dosing time to the last measurement time point with a concentration value above the lower limit of quantitation, calculated by means of the linear up/log down method (linear trapezoidal rule for increases in concentration/logarithmic trapezoidal rule for decreases in concentrations. Blood samples were collected at indicated timepoints for the analysis of AUC0-tlast). PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Test Product
n=53 Participants
Participants were randomly assigned as per cross over design to receive oral administration of one paracetamol ODT as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
Reference Product 1
n=53 Participants
Participants were randomly assigned as per cross over design to receive oral administration of one Alvedon film-coated tablet as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
|---|---|---|
|
AUC0-tlast for Paracetamol ODT (Test) vs. Paracetamol (Panadol Film-coated Tablet) (Reference 2)
|
23.9 h*µg/mL
Geometric Coefficient of Variation 36.6
|
24.5 h*µg/mL
Geometric Coefficient of Variation 34.9
|
PRIMARY outcome
Timeframe: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment periodPopulation: PKAS Population. Only those participants with data available at the specified timepoint were analyzed.
Blood samples were collected at indicated timepoints for the analysis of tmax. PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Test Product
n=53 Participants
Participants were randomly assigned as per cross over design to receive oral administration of one paracetamol ODT as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
Reference Product 1
n=53 Participants
Participants were randomly assigned as per cross over design to receive oral administration of one Alvedon film-coated tablet as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
|---|---|---|
|
Tmax for Paracetamol ODT (Test) vs. Paracetamol (Panadol Film-coated Tablet) (Reference 2)
|
1.00 h
Interval 0.42 to 2.0
|
0.500 h
Interval 0.25 to 3.0
|
SECONDARY outcome
Timeframe: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment periodPopulation: PKAS Population. Only those participants with data available at the specified timepoint were analyzed.
AUC (0-inf) equal to(=) AUC0-tlast addition(+) AUCexpol, where AUCexpol = Clast/Lz, where Clast was observed concentration at the last time point with a concentration value above the lower limit of quantitation, directly taken from measured concentration values and Lz was apparent terminal elimination rate constant determined by log-linear regression(Lz); the regression generally involved at least 3 consecutive measurable concentrations that decreased over time. Blood samples were collected at indicated timepoints for the analysis of AUC (0-inf). PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Test Product
n=53 Participants
Participants were randomly assigned as per cross over design to receive oral administration of one paracetamol ODT as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
Reference Product 1
Participants were randomly assigned as per cross over design to receive oral administration of one Alvedon film-coated tablet as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
|---|---|---|
|
Area Under the Plasma Concentration vs. Time Curve Calculated From Time Zero to Infinity [AUC (0-inf)] for Paracetamol ODT (Test)
|
24.6 h*µg/mL
Geometric Coefficient of Variation 36.3
|
—
|
SECONDARY outcome
Timeframe: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment periodPopulation: PKAS Population. Only those participants with data available at the specified timepoint were analyzed.
AUC (0-inf)= AUC0-tlast + AUCexpol, where AUCexpol = Clast/Lz, where Clast was observed concentration at the last time point with a concentration value above the lower limit of quantitation, directly taken from measured concentration values and Lz was apparent terminal elimination rate constant determined by log-linear regression; the regression generally involved at least 3 consecutive measurable concentrations that decreased over time. Blood samples were collected at indicated timepoints for the analysis of AUC (0-inf). PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Test Product
n=51 Participants
Participants were randomly assigned as per cross over design to receive oral administration of one paracetamol ODT as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
Reference Product 1
Participants were randomly assigned as per cross over design to receive oral administration of one Alvedon film-coated tablet as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
|---|---|---|
|
AUC (0-inf) for Paracetamol (Alvedon Film-coated Tablet) (Reference 1)
|
25.1 h*µg/mL
Geometric Coefficient of Variation 37.3
|
—
|
SECONDARY outcome
Timeframe: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment periodPopulation: PKAS Population. Only those participants with data available at the specified timepoint were analyzed.
AUC (0-inf)= AUC0-tlast + AUCexpol, where AUCexpol = Clast/Lz, where Clast was observed concentration at the last time point with a concentration value above the lower limit of quantitation, directly taken from measured concentration values and Lz was apparent terminal elimination rate constant determined by log-linear regression; the regression generally involved at least 3 consecutive measurable concentrations that decreased over time. Blood samples were collected at indicated timepoints for the analysis of AUC (0-inf). PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Test Product
n=53 Participants
Participants were randomly assigned as per cross over design to receive oral administration of one paracetamol ODT as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
Reference Product 1
Participants were randomly assigned as per cross over design to receive oral administration of one Alvedon film-coated tablet as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
|---|---|---|
|
AUC (0-inf) for Paracetamol (Panadol Film-coated Tablet) (Reference 2)
|
25.3 h*µg/mL
Geometric Coefficient of Variation 34.6
|
—
|
SECONDARY outcome
Timeframe: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment periodPopulation: PKAS Population. Only those participants with data available at the specified timepoint were analyzed.
AUCexpol%= AUCexpol multiplied by (\*)100/AUC0-inf, where AUCexpol = Clast/Lz. Blood samples were collected at indicated timepoints for the analysis of AUCexpol%. PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Test Product
n=53 Participants
Participants were randomly assigned as per cross over design to receive oral administration of one paracetamol ODT as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
Reference Product 1
Participants were randomly assigned as per cross over design to receive oral administration of one Alvedon film-coated tablet as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
|---|---|---|
|
AUCexpol% for Paracetamol ODT (Test)
|
2.57 percentage
Geometric Coefficient of Variation 43.1
|
—
|
SECONDARY outcome
Timeframe: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment periodPopulation: PKAS Population. Only those participants with data available at the specified timepoint were analyzed.
AUCexpol%= AUCexpol\*100/AUC0-inf, where AUCexpol = Clast/Lz. Blood samples were collected at indicated timepoints for the analysis of AUCexpol%. PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Test Product
n=51 Participants
Participants were randomly assigned as per cross over design to receive oral administration of one paracetamol ODT as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
Reference Product 1
Participants were randomly assigned as per cross over design to receive oral administration of one Alvedon film-coated tablet as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
|---|---|---|
|
AUCexpol% for Paracetamol (Alvedon Film-coated Tablet) (Reference 1)
|
2.74 percentage
Geometric Coefficient of Variation 44.8
|
—
|
SECONDARY outcome
Timeframe: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment periodPopulation: PKAS Population. Only those participants with data available at the specified timepoint were analyzed.
AUCexpol%= AUCexpol\*100/AUC0-inf, where AUCexpol = Clast/Lz. Blood samples were collected at indicated timepoints for the analysis of AUCexpol%. PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Test Product
n=53 Participants
Participants were randomly assigned as per cross over design to receive oral administration of one paracetamol ODT as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
Reference Product 1
Participants were randomly assigned as per cross over design to receive oral administration of one Alvedon film-coated tablet as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
|---|---|---|
|
AUCexpol% for Paracetamol (Panadol Film-coated Tablet) (Reference 2)
|
2.64 percentage
Geometric Coefficient of Variation 56.5
|
—
|
SECONDARY outcome
Timeframe: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment periodPopulation: PKAS Population. Only those participants with data available at the specified timepoint were analyzed.
Lz was an apparent terminal elimination rate constant determined by log-linear regression; the regression generally involved at least 3 consecutive measurable concentrations that decreased over time. Blood samples were collected at indicated timepoints for the analysis of Lz. PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Test Product
n=53 Participants
Participants were randomly assigned as per cross over design to receive oral administration of one paracetamol ODT as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
Reference Product 1
Participants were randomly assigned as per cross over design to receive oral administration of one Alvedon film-coated tablet as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
|---|---|---|
|
Lz for Paracetamol ODT (Test)
|
0.148 1/h
Geometric Coefficient of Variation 30.3
|
—
|
SECONDARY outcome
Timeframe: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment periodPopulation: PKAS Population. Only those participants with data available at the specified timepoint were analyzed.
Lz was an apparent terminal elimination rate constant determined by log-linear regression; the regression generally involved at least 3 consecutive measurable concentrations that decreased over time. Blood samples were collected at indicated timepoints for the analysis of Lz. PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Test Product
n=51 Participants
Participants were randomly assigned as per cross over design to receive oral administration of one paracetamol ODT as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
Reference Product 1
Participants were randomly assigned as per cross over design to receive oral administration of one Alvedon film-coated tablet as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
|---|---|---|
|
Lz for Paracetamol (Alvedon Film-coated Tablet) (Reference 1)
|
0.140 1/h
Geometric Coefficient of Variation 30.1
|
—
|
SECONDARY outcome
Timeframe: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment periodPopulation: PKAS Population. Only those participants with data available at the specified timepoint were analyzed.
Lz was an apparent terminal elimination rate constant determined by log-linear regression; the regression generally involved at least 3 consecutive measurable concentrations that decreased over time. Blood samples were collected at indicated timepoints for the analysis of Lz. PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Test Product
n=53 Participants
Participants were randomly assigned as per cross over design to receive oral administration of one paracetamol ODT as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
Reference Product 1
Participants were randomly assigned as per cross over design to receive oral administration of one Alvedon film-coated tablet as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
|---|---|---|
|
Lz for Paracetamol (Panadol Film-coated Tablet) (Reference 2)
|
0.143 1/h
Geometric Coefficient of Variation 34.8
|
—
|
SECONDARY outcome
Timeframe: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment periodPopulation: PKAS Population. Only those participants with data available at the specified timepoint were analyzed.
t1/2 = ln(2) / Lz. Blood samples were collected at indicated timepoints for the analysis of t1/2. PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Test Product
n=53 Participants
Participants were randomly assigned as per cross over design to receive oral administration of one paracetamol ODT as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
Reference Product 1
Participants were randomly assigned as per cross over design to receive oral administration of one Alvedon film-coated tablet as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
|---|---|---|
|
Apparent Terminal Elimination Half-life (t1/2) for Paracetamol ODT (Test)
|
4.73 h
Interval 2.67 to 10.7
|
—
|
SECONDARY outcome
Timeframe: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment periodPopulation: PKAS Population. Only those participants with data available at the specified timepoint were analyzed.
t1/2 = ln(2) / Lz. Blood samples were collected at indicated timepoints for the analysis of t1/2. PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Test Product
n=51 Participants
Participants were randomly assigned as per cross over design to receive oral administration of one paracetamol ODT as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
Reference Product 1
Participants were randomly assigned as per cross over design to receive oral administration of one Alvedon film-coated tablet as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
|---|---|---|
|
t1/2 for Paracetamol (Alvedon Film-coated Tablet) (Reference 1)
|
5.03 h
Interval 2.67 to 8.96
|
—
|
SECONDARY outcome
Timeframe: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment periodPopulation: PKAS Population. Only those participants with data available at the specified timepoint were analyzed.
t1/2 = ln(2) / Lz. Blood samples were collected at indicated timepoints for the analysis of t1/2. PK parameters were determined by non-compartmental analysis.
Outcome measures
| Measure |
Test Product
n=53 Participants
Participants were randomly assigned as per cross over design to receive oral administration of one paracetamol ODT as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
Reference Product 1
Participants were randomly assigned as per cross over design to receive oral administration of one Alvedon film-coated tablet as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
|---|---|---|
|
t1/2 for Paracetamol (Panadol Film-coated Tablet) (Reference 2)
|
4.75 h
Interval 2.53 to 12.5
|
—
|
Adverse Events
Test Product
Reference Product 1
Reference Product 2
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Product
n=53 participants at risk
Participants were randomly assigned as per cross over design to receive oral administration of one paracetamol (ODT) as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
Reference Product 1
n=53 participants at risk
Participants were randomly assigned as per cross over design to receive oral administration of one Alvedon film-coated tablet as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
Reference Product 2
n=53 participants at risk
Participants were randomly assigned as per cross over design to receive oral administration of one Panadol film-coated tablet as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).
|
|---|---|---|---|
|
Nervous system disorders
Dizziness
|
1.9%
1/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
|
Nervous system disorders
Migraine
|
1.9%
1/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
|
Investigations
Blood thyroid stimulating hormone increased
|
1.9%
1/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
1.9%
1/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
|
Gastrointestinal disorders
Abdominal distension
|
1.9%
1/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.9%
1/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
|
Gastrointestinal disorders
Nausea
|
3.8%
2/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
1.9%
1/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
|
Infections and infestations
Urinary tract infection
|
1.9%
1/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
1.9%
1/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
|
Investigations
Blood cholesterol increased
|
1.9%
1/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
|
Investigations
Blood pressure diastolic increased
|
1.9%
1/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
1.9%
1/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
1.9%
1/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
|
Investigations
Blood pressure increased
|
1.9%
1/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
|
Nervous system disorders
Presyncope
|
1.9%
1/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
5.7%
3/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
1.9%
1/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
1.9%
1/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
1.9%
1/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
1.9%
1/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
1.9%
1/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
1.9%
1/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
|
Investigations
Cardiac murmur
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
1.9%
1/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
1.9%
1/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
|
Nervous system disorders
Headache
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
5.7%
3/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
1.9%
1/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
1.9%
1/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
1.9%
1/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
|
General disorders
Malaise
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
1.9%
1/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
1.9%
1/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
0.00%
0/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
1.9%
1/53 • Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee HALEON agreements may vary with individual investigators but will not prohibit any investigator from publishing. HALEON 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