Trial Outcomes & Findings for Topiramate 25 mg Capsules Under Fed Conditions (NCT NCT00904943)

NCT ID: NCT00904943

Last Updated: 2024-09-19

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 18 participants
• Primary outcome timeframe: Blood samples collected over 168 hour period
• Results posted on: 2024-09-19

Participant Flow

Participant milestones

Measure	Topiramate (Test) First Topiramate Capsules, 2 x 25 mg (test) dosed in first period followed by Topamax® Capsules, 2 x 25 mg (reference) dosed in second period	Topamax® (Reference) First Topamax® Capsules, 2 x 25 mg (reference) dosed in first period followed by Topiramate Capsules, 2 x 25 mg (test) dosed in second period
Period 1 STARTED	9	9
Period 1 COMPLETED	9	9
Period 1 NOT COMPLETED	0	0
Period 2 STARTED	9	8
Period 2 COMPLETED	9	8
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Topiramate 25 mg Capsules Under Fed Conditions

Baseline characteristics by cohort

Measure	Topiramate (Test) First n=9 Participants Topiramate Capsules, 2 x 25 mg (test) dosed in first period followed by Topamax® Capsules, 2 x 25 mg (reference) dosed in second period	Topamax® (Reference) First n=9 Participants Topamax® Capsules, 2 x 25 mg (reference) dosed in first period followed by Topiramate Capsules, 2 x 25 mg (test) dosed in second period	Total n=18 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	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Canada	9 participants n=5 Participants	9 participants n=7 Participants	18 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 168 hour period

Population: Data from all subjects that completed the study was included in the statistical analysis.

Bioequivalence based on Cmax

Outcome measures

Measure	Topiramate (Test) n=17 Participants Topiramate Capsules, 2 x 25 mg dosed in either period	Topamax® (Reference) n=17 Participants Topamax® Capsules, 2 x 25 mg dosed in either period
Cmax - Maximum Observed Concentration	573.29 ng/mL Standard Deviation 163.05	550.55 ng/mL Standard Deviation 161.55

PRIMARY outcome

Timeframe: Blood samples collected over 168 hour period

Population: Data from all subjects that completed the study was included in the statistical analysis.

Bioequivalence based on AUC0-inf

Outcome measures

Measure	Topiramate (Test) n=17 Participants Topiramate Capsules, 2 x 25 mg dosed in either period	Topamax® (Reference) n=17 Participants Topamax® Capsules, 2 x 25 mg dosed in either period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	34657.80 ng*hr/mL Standard Deviation 8059.56	33592.62 ng*hr/mL Standard Deviation 7059.10

PRIMARY outcome

Timeframe: Blood samples collected over 168 hour period

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

Bioequivalence based on AUC0-t

Outcome measures

Measure	Topiramate (Test) n=17 Participants Topiramate Capsules, 2 x 25 mg dosed in either period	Topamax® (Reference) n=17 Participants Topamax® Capsules, 2 x 25 mg dosed in either period
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)	30342.73 ng*hr/mL Standard Deviation 7475.76	29129.82 ng*hr/mL Standard Deviation 6960.37

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 PI is not permitted to discuss or publish trial results.
• Publication restrictions are in place

Restriction type: OTHER