Trial Outcomes & Findings for Bioequivalence Study of Two Nitisinone Formulations Compared to Orfadin (NCT NCT02750709)
NCT ID: NCT02750709
Last Updated: 2017-03-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours
Results posted on
2017-03-15
Participant Flow
Participant milestones
| Measure |
Treatment Sequence A (TP 1) - B (TP 2) - C (Reference)
Subjects will receive a single 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 1, 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 2, and 10 mg hard capsule of Orfadin (Reference) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.
Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.
Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.
Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state.
|
Treatment Sequence A (TP 1) - C (Reference) - B (TP 2)
Subjects will receive a single 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 2) in treatment period 1, 10 mg hard capsule of Orfadin (Reference) in treatment period 2, and 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.
Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.
Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.
Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state.
|
Treatment Sequence B (TP 2) - A (TP 1) - C (Reference)
Subjects will receive a single 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 1, 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 2, and 10 mg hard capsule of Orfadin (Reference) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.
Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.
Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.
Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state.
|
Treatment Sequence B (TP 2) - C (Reference) - A (TP 1)
Subjects will receive a single 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 1, 10 mg hard capsule of Orfadin (Reference) in treatment period 2, and 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 3, and under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.
Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.
Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.
Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state.
|
Treatment Sequence C (Reference) - A (TP 1) - B (TP 2)
Subjects will receive a single 10 mg hard capsule of Orfadin (Reference) in treatment period 1, 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 2, and 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.
Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.
Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.
Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state.
|
Treatment Sequence C (Reference) - B (TP 2) - A (TP 1)
Subjects will receive a single 10 mg hard capsule of Orfadin (Reference) in treatment period 1, 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 2, 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.
Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.
Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.
Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state.
|
|---|---|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Treatment Period 1
COMPLETED
|
4
|
4
|
4
|
4
|
4
|
3
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period 2
STARTED
|
4
|
4
|
4
|
4
|
4
|
3
|
|
Treatment Period 2
COMPLETED
|
4
|
4
|
4
|
4
|
4
|
3
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 3
STARTED
|
4
|
4
|
4
|
4
|
4
|
3
|
|
Treatment Period 3
COMPLETED
|
4
|
4
|
4
|
4
|
4
|
3
|
|
Treatment Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment Sequence A (TP 1) - B (TP 2) - C (Reference)
Subjects will receive a single 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 1, 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 2, and 10 mg hard capsule of Orfadin (Reference) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.
Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.
Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.
Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state.
|
Treatment Sequence A (TP 1) - C (Reference) - B (TP 2)
Subjects will receive a single 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 2) in treatment period 1, 10 mg hard capsule of Orfadin (Reference) in treatment period 2, and 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.
Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.
Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.
Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state.
|
Treatment Sequence B (TP 2) - A (TP 1) - C (Reference)
Subjects will receive a single 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 1, 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 2, and 10 mg hard capsule of Orfadin (Reference) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.
Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.
Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.
Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state.
|
Treatment Sequence B (TP 2) - C (Reference) - A (TP 1)
Subjects will receive a single 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 1, 10 mg hard capsule of Orfadin (Reference) in treatment period 2, and 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 3, and under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.
Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.
Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.
Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state.
|
Treatment Sequence C (Reference) - A (TP 1) - B (TP 2)
Subjects will receive a single 10 mg hard capsule of Orfadin (Reference) in treatment period 1, 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 2, and 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.
Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.
Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.
Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state.
|
Treatment Sequence C (Reference) - B (TP 2) - A (TP 1)
Subjects will receive a single 10 mg hard capsule of Orfadin (Reference) in treatment period 1, 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 2, 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.
Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.
Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.
Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state.
|
|---|---|---|---|---|---|---|
|
Treatment Period 1
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Bioequivalence Study of Two Nitisinone Formulations Compared to Orfadin
Baseline characteristics by cohort
| Measure |
All Study Participants
n=24 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black
|
15 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
7 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Coloured
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
South Africa
|
24 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hoursPopulation: All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.
Outcome measures
| Measure |
Treatment Period 1
n=23 Participants
Nitisinone Tablet, 10 mg
|
Treatment Period 2
n=23 Participants
Nitisinone Tablet (High Compritol), 10 mg
|
Reference Product
n=23 Participants
ORFADIN® hard capsule, 10 mg
|
|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
1137.40 ng/mL
Geometric Coefficient of Variation 17.9
|
1080.69 ng/mL
Geometric Coefficient of Variation 24.2
|
1168.71 ng/mL
Geometric Coefficient of Variation 22.6
|
PRIMARY outcome
Timeframe: 0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hoursPopulation: All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.
Outcome measures
| Measure |
Treatment Period 1
n=23 Participants
Nitisinone Tablet, 10 mg
|
Treatment Period 2
n=23 Participants
Nitisinone Tablet (High Compritol), 10 mg
|
Reference Product
n=23 Participants
ORFADIN® hard capsule, 10 mg
|
|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve, From Time Zero to 120 Hours Post-dose (AUC(0-120))
|
66220.91 hr*ng/mL
Geometric Coefficient of Variation 19.0
|
61883.52 hr*ng/mL
Geometric Coefficient of Variation 23.1
|
66199.76 hr*ng/mL
Geometric Coefficient of Variation 18.7
|
SECONDARY outcome
Timeframe: 0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dosePopulation: All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.
Outcome measures
| Measure |
Treatment Period 1
n=23 Participants
Nitisinone Tablet, 10 mg
|
Treatment Period 2
n=23 Participants
Nitisinone Tablet (High Compritol), 10 mg
|
Reference Product
n=23 Participants
ORFADIN® hard capsule, 10 mg
|
|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve, From Time Zero to 72 Hours Post-dose (AUC(0-72))
|
49448.49 hr*ng/mL
Geometric Coefficient of Variation 19.8
|
46401.12 hr*ng/mL
Geometric Coefficient of Variation 37.6
|
49582.69 hr*ng/mL
Geometric Coefficient of Variation 19.2
|
SECONDARY outcome
Timeframe: 0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hoursPopulation: All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.
Outcome measures
| Measure |
Treatment Period 1
n=23 Participants
Nitisinone Tablet, 10 mg
|
Treatment Period 2
n=23 Participants
Nitisinone Tablet (High Compritol), 10 mg
|
Reference Product
n=23 Participants
ORFADIN® hard capsule, 10 mg
|
|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC(0-∞)
|
91226.27 hr*ng/mL
Geometric Coefficient of Variation 26.6
|
83245.33 hr*ng/mL
Geometric Coefficient of Variation 37.0
|
89394.35 hr*ng/mL
Geometric Coefficient of Variation 23.7
|
SECONDARY outcome
Timeframe: 0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hoursPopulation: All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.
Outcome measures
| Measure |
Treatment Period 1
n=23 Participants
Nitisinone Tablet, 10 mg
|
Treatment Period 2
n=23 Participants
Nitisinone Tablet (High Compritol), 10 mg
|
Reference Product
n=23 Participants
ORFADIN® hard capsule, 10 mg
|
|---|---|---|---|
|
Time to Maximum Observed Plasma Concentration (Tmax)
|
3.00 hr
Interval 2.0 to 5.0
|
3.00 hr
Interval 1.0 to 7.0
|
2.50 hr
Interval 0.5 to 8.0
|
SECONDARY outcome
Timeframe: 0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hoursPopulation: All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.
Outcome measures
| Measure |
Treatment Period 1
n=23 Participants
Nitisinone Tablet, 10 mg
|
Treatment Period 2
n=23 Participants
Nitisinone Tablet (High Compritol), 10 mg
|
Reference Product
n=23 Participants
ORFADIN® hard capsule, 10 mg
|
|---|---|---|---|
|
Terminal Elimination Rate Constant (λz)
|
0.011 1/hr
Geometric Coefficient of Variation 29.1
|
0.012 1/hr
Geometric Coefficient of Variation 20.6
|
0.012 1/hr
Geometric Coefficient of Variation 25.2
|
SECONDARY outcome
Timeframe: 0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hoursPopulation: All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.
Outcome measures
| Measure |
Treatment Period 1
n=23 Participants
Nitisinone Tablet, 10 mg
|
Treatment Period 2
n=23 Participants
Nitisinone Tablet (High Compritol), 10 mg
|
Reference Product
n=23 Participants
ORFADIN® hard capsule, 10 mg
|
|---|---|---|---|
|
Apparent Terminal Half-life (t1/2)
|
61.42 hr
Geometric Coefficient of Variation 29.1
|
58.41 hr
Geometric Coefficient of Variation 20.6
|
59.43 hr
Geometric Coefficient of Variation 25.2
|
Adverse Events
Test Product 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Test Product 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Reference Product
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Product 1
n=23 participants at risk
Nitisinone Tablet, 10 mg
|
Test Product 2
n=23 participants at risk
Nitisinone Tablet (High Compritol), 10 mg
|
Reference Product
n=24 participants at risk
ORFADIN® hard capsule, 10 mg
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
4.3%
1/23 • Number of events 1 • Adverse event data were collected over the period of the study (December 2015 - January 2016).
24 subjects were entered in to the study and randomly assigned to treatment sequence according to randomization schedule before first administration of the Investigational Medicinal Product (IMP). One subject was withdrawn from the study after Treatment Period 1 (Reference Product) because they vomited within 2 times median Tmax. As a result, 24 subjects completed dosing of Reference Product and 23 subjects completed the study.
|
0.00%
0/23 • Adverse event data were collected over the period of the study (December 2015 - January 2016).
24 subjects were entered in to the study and randomly assigned to treatment sequence according to randomization schedule before first administration of the Investigational Medicinal Product (IMP). One subject was withdrawn from the study after Treatment Period 1 (Reference Product) because they vomited within 2 times median Tmax. As a result, 24 subjects completed dosing of Reference Product and 23 subjects completed the study.
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected over the period of the study (December 2015 - January 2016).
24 subjects were entered in to the study and randomly assigned to treatment sequence according to randomization schedule before first administration of the Investigational Medicinal Product (IMP). One subject was withdrawn from the study after Treatment Period 1 (Reference Product) because they vomited within 2 times median Tmax. As a result, 24 subjects completed dosing of Reference Product and 23 subjects completed the study.
|
|
Skin and subcutaneous tissue disorders
Itching Fingers
|
0.00%
0/23 • Adverse event data were collected over the period of the study (December 2015 - January 2016).
24 subjects were entered in to the study and randomly assigned to treatment sequence according to randomization schedule before first administration of the Investigational Medicinal Product (IMP). One subject was withdrawn from the study after Treatment Period 1 (Reference Product) because they vomited within 2 times median Tmax. As a result, 24 subjects completed dosing of Reference Product and 23 subjects completed the study.
|
4.3%
1/23 • Number of events 1 • Adverse event data were collected over the period of the study (December 2015 - January 2016).
24 subjects were entered in to the study and randomly assigned to treatment sequence according to randomization schedule before first administration of the Investigational Medicinal Product (IMP). One subject was withdrawn from the study after Treatment Period 1 (Reference Product) because they vomited within 2 times median Tmax. As a result, 24 subjects completed dosing of Reference Product and 23 subjects completed the study.
|
0.00%
0/24 • Adverse event data were collected over the period of the study (December 2015 - January 2016).
24 subjects were entered in to the study and randomly assigned to treatment sequence according to randomization schedule before first administration of the Investigational Medicinal Product (IMP). One subject was withdrawn from the study after Treatment Period 1 (Reference Product) because they vomited within 2 times median Tmax. As a result, 24 subjects completed dosing of Reference Product and 23 subjects completed the study.
|
|
Nervous system disorders
Vaso Vagal Attack
|
0.00%
0/23 • Adverse event data were collected over the period of the study (December 2015 - January 2016).
24 subjects were entered in to the study and randomly assigned to treatment sequence according to randomization schedule before first administration of the Investigational Medicinal Product (IMP). One subject was withdrawn from the study after Treatment Period 1 (Reference Product) because they vomited within 2 times median Tmax. As a result, 24 subjects completed dosing of Reference Product and 23 subjects completed the study.
|
0.00%
0/23 • Adverse event data were collected over the period of the study (December 2015 - January 2016).
24 subjects were entered in to the study and randomly assigned to treatment sequence according to randomization schedule before first administration of the Investigational Medicinal Product (IMP). One subject was withdrawn from the study after Treatment Period 1 (Reference Product) because they vomited within 2 times median Tmax. As a result, 24 subjects completed dosing of Reference Product and 23 subjects completed the study.
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected over the period of the study (December 2015 - January 2016).
24 subjects were entered in to the study and randomly assigned to treatment sequence according to randomization schedule before first administration of the Investigational Medicinal Product (IMP). One subject was withdrawn from the study after Treatment Period 1 (Reference Product) because they vomited within 2 times median Tmax. As a result, 24 subjects completed dosing of Reference Product and 23 subjects completed the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place