Trial Outcomes & Findings for Oxcarbazepine 600 mg Tablets Under Non-Fasting Conditions (NCT NCT00849797)

NCT ID: NCT00849797

Last Updated: 2024-08-19

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 120 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	60	60
First Intervention COMPLETED	59	59
First Intervention NOT COMPLETED	1	1
Washout: One Week STARTED	59	59
Washout: One Week COMPLETED	59	57
Washout: One Week NOT COMPLETED	0	2
Second Intervention STARTED	59	57
Second Intervention COMPLETED	59	57
Second Intervention NOT COMPLETED	0	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
First Intervention bad veins	1	0
First Intervention Adverse Event	0	1
Washout: One Week Withdrawal by Subject	0	2

Baseline Characteristics

Oxcarbazepine 600 mg Tablets Under Non-Fasting Conditions

Baseline characteristics by cohort

Measure	Oxcarbazepine (Test) First n=60 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=60 Participants Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period	Total n=120 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	58 Participants n=5 Participants	56 Participants n=7 Participants	114 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	27 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	33 Participants n=7 Participants	68 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	48 Participants n=5 Participants	51 Participants n=7 Participants	99 Participants n=5 Participants
Race/Ethnicity, Customized American Hispanic	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Black	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment Canada	60 participants n=5 Participants	60 participants n=7 Participants	120 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 48 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on Cmax

Outcome measures

Measure	Oxcarbazepine n=116 Participants Oxcarbazepine 600 mg Tablet (test) dosed in either period	Trileptal® n=116 Participants Trileptal® 600 mg Tablet (reference) dosed in either period
Cmax - Maximum Observed Concentration - Oxcarbazepine in Plasma	3537.63 ng/mL Standard Deviation 1333.09	3820.31 ng/mL Standard Deviation 1357.08

PRIMARY outcome

Timeframe: Blood samples collected over 48 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on AUC0-inf

Outcome measures

Measure	Oxcarbazepine n=116 Participants Oxcarbazepine 600 mg Tablet (test) dosed in either period	Trileptal® n=116 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	9679.79 ng*h/mL Standard Deviation 2371.03	9772.18 ng*h/mL Standard Deviation 2350.44

PRIMARY outcome

Timeframe: Blood samples collected over 48 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on AUC0-t

Outcome measures

Measure	Oxcarbazepine n=116 Participants Oxcarbazepine 600 mg Tablet (test) dosed in either period	Trileptal® n=116 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	9445.55 ng*h/mL Standard Deviation 2327.24	9539.53 ng*h/mL Standard Deviation 2293.33

SECONDARY outcome

Timeframe: Blood samples collected over 48 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Informational Purposes Only

Outcome measures

Measure	Oxcarbazepine n=116 Participants Oxcarbazepine 600 mg Tablet (test) dosed in either period	Trileptal® n=116 Participants Trileptal® 600 mg Tablet (reference) dosed in either period
Cmax - 10-hydroxy-carbazepine in Plasma	9349.83 ng/mL Standard Deviation 1739.68	9517.52 ng/mL Standard Deviation 2034.08

SECONDARY outcome

Timeframe: Blood samples collected over 48 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Informational Purposes Only

Outcome measures

Measure	Oxcarbazepine n=116 Participants Oxcarbazepine 600 mg Tablet (test) dosed in either period	Trileptal® n=116 Participants Trileptal® 600 mg Tablet (reference) dosed in either period
AUC0-inf - 10-Hydroxy-Carbazepine Metabolite	197864.34 ng*h/mL Standard Deviation 47069.89	196607.20 ng*h/mL Standard Deviation 43337.72

SECONDARY outcome

Timeframe: Blood samples collected over 48 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Informational Purposes Only

Outcome measures

Measure	Oxcarbazepine n=116 Participants Oxcarbazepine 600 mg Tablet (test) dosed in either period	Trileptal® n=116 Participants Trileptal® 600 mg Tablet (reference) dosed in either period
AUC0-t - 10-Hydroxy-Carbazepine Metabolite	179002.40 ng*h/mL Standard Deviation 39157.51	177979.76 ng*h/mL Standard Deviation 35506.55

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manager, Biopharmaceutics

Teva Pharmaceuticals USA

Phone: 1-866-384-5525

Email: clinicaltrialqueries@tevausa.com

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