Trial Outcomes & Findings for Topiramate 25 mg Capsules Under Fasting Conditions (NCT NCT00905164)

NCT ID: NCT00905164

Last Updated: 2024-09-19

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 24 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 Topomax® Capsules, 2 x 25 mg (reference) dosed in second period	Topomax® (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	12	12
Period 1 COMPLETED	12	11
Period 1 NOT COMPLETED	0	1
Period 2 STARTED	12	11
Period 2 COMPLETED	12	11
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Topiramate (Test) First Topiramate Capsules, 2 x 25 mg (test) dosed in first period followed by Topomax® Capsules, 2 x 25 mg (reference) dosed in second period	Topomax® (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 Protocol Violation	0	1

Baseline Characteristics

Topiramate 25 mg Capsules Under Fasting Conditions

Baseline characteristics by cohort

Measure	Topiramate (Test) First n=12 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=12 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=24 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	12 Participants n=5 Participants	12 Participants n=7 Participants	24 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	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized American Hispanic	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Canada	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants

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 Cmax

Outcome measures

Measure	Topiramate (Test) n=23 Participants Topiramate Capsules, 2 x 25 mg dosed in either period	Topamax® (Reference) n=23 Participants Topamax® Capsules, 2 x 25 mg dosed in either period
Cmax - Maximum Observed Concentration	799.78 ng/mL Standard Deviation 263.94	810.40 ng/mL Standard Deviation 255.47

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-inf

Outcome measures

Measure	Topiramate (Test) n=23 Participants Topiramate Capsules, 2 x 25 mg dosed in either period	Topamax® (Reference) n=23 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)	37553.92 ng*hr/mL Standard Deviation 7995.76	37985.24 ng*hr/mL Standard Deviation 7790.42

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=23 Participants Topiramate Capsules, 2 x 25 mg dosed in either period	Topamax® (Reference) n=23 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)	32844.22 ng*hr/mL Standard Deviation 7746.34	32915.59 ng*hr/mL Standard Deviation 7694.56

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