Trial Outcomes & Findings for Oxcarbazepine 600 mg Tablets Under Fasting Conditions (NCT NCT00850174)
NCT ID: NCT00850174
Last Updated: 2024-08-19
Results Overview
Bioequivalence based on Cmax
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
Blood samples collected over 48 hour period
Results posted on
2024-08-19
Participant Flow
Participant milestones
| Measure |
Oxcarbazepine (Test) First
Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period
|
Trileptal® (Reference) First
Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period
|
|---|---|---|
|
First Intervention
STARTED
|
30
|
30
|
|
First Intervention
COMPLETED
|
30
|
30
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout: One Week
STARTED
|
30
|
30
|
|
Washout: One Week
COMPLETED
|
30
|
28
|
|
Washout: One Week
NOT COMPLETED
|
0
|
2
|
|
Second Intervention
STARTED
|
30
|
28
|
|
Second Intervention
COMPLETED
|
29
|
28
|
|
Second Intervention
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Oxcarbazepine (Test) First
Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period
|
Trileptal® (Reference) First
Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period
|
|---|---|---|
|
Washout: One Week
Withdrawal by Subject
|
0
|
2
|
|
Second Intervention
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Oxcarbazepine 600 mg Tablets Under Fasting Conditions
Baseline characteristics by cohort
| Measure |
Oxcarbazepine (Test) First
n=30 Participants
Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period
|
Trileptal® (Reference) First
n=30 Participants
Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
15 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
10 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
30 participants
n=99 Participants
|
30 participants
n=107 Participants
|
60 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over 48 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on Cmax
Outcome measures
| Measure |
Oxcarbazepine
n=57 Participants
Oxcarbazepine 600 mg Tablet (test) dosed in either period
|
Trileptal®
n=57 Participants
Trileptal® 600 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
Cmax - Maximum Observed Concentration - Oxcarbazepine in Plasma
|
1630.3 ng/mL
Standard Deviation 662.6
|
1620.2 ng/mL
Standard Deviation 644.3
|
PRIMARY outcome
Timeframe: Blood samples collected over 48 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis. AUC0-inf was not able to be estimated from all data sets.
Bioequivalence based on AUC0-inf
Outcome measures
| Measure |
Oxcarbazepine
n=53 Participants
Oxcarbazepine 600 mg Tablet (test) dosed in either period
|
Trileptal®
n=54 Participants
Trileptal® 600 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Oxcarbazepine
|
5873.1 ng*h/mL
Standard Deviation 1598.8
|
5711.7 ng*h/mL
Standard Deviation 1472.3
|
PRIMARY outcome
Timeframe: Blood samples collected over 48 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on AUC0-t
Outcome measures
| Measure |
Oxcarbazepine
n=57 Participants
Oxcarbazepine 600 mg Tablet (test) dosed in either period
|
Trileptal®
n=57 Participants
Trileptal® 600 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Oxcarbazepine
|
5309.5 ng*h/mL
Standard Deviation 1598.1
|
5176.8 ng*h/mL
Standard Deviation 1494.4
|
SECONDARY outcome
Timeframe: Blood samples collected over 48 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Results of Metabolite for Informational Purposes Only
Outcome measures
| Measure |
Oxcarbazepine
n=57 Participants
Oxcarbazepine 600 mg Tablet (test) dosed in either period
|
Trileptal®
n=57 Participants
Trileptal® 600 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
Cmax - 10-hydroxy-carbazepine in Plasma
|
7119 ng/mL
Standard Deviation 1663
|
7004 ng/mL
Standard Deviation 1410
|
SECONDARY outcome
Timeframe: Blood samples collected over 48 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Results of Metabolite for informational purposes only
Outcome measures
| Measure |
Oxcarbazepine
n=57 Participants
Oxcarbazepine 600 mg Tablet (test) dosed in either period
|
Trileptal®
n=57 Participants
Trileptal® 600 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
AUC0-inf - 10-hydroxy-carbazepine Metabolite
|
173770 ng*h/mL
Standard Deviation 37809
|
174424 ng*h/mL
Standard Deviation 44645
|
SECONDARY outcome
Timeframe: Blood samples collected over 48 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Results of metabolite for informational purposes only
Outcome measures
| Measure |
Oxcarbazepine
n=57 Participants
Oxcarbazepine 600 mg Tablet (test) dosed in either period
|
Trileptal®
n=57 Participants
Trileptal® 600 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
AUC0-t - 10-hydroxy-carbazepine Metabolite
|
157372 ng*h/mL
Standard Deviation 29483
|
157542 ng*h/mL
Standard Deviation 31906
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigator is not permitted to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER