Trial Outcomes & Findings for Topiramate 25 mg Tablets Under Fasting Conditions (NCT NCT00905606)

NCT ID: NCT00905606

Last Updated: 2024-08-19

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 30 participants
• Primary outcome timeframe: Blood samples collected over 96 hour period
• Results posted on: 2024-08-19

Participant Flow

Participant milestones

Measure	Topiramate (Test) First Topiramate Tablets, 2 x 25 mg test product dosed in first period followed by Topomax® Tablets, 2 x 25 mg reference product dosed in second period.	Topamax® (Reference) First Topamax® Tablets, 2 x 25 mg reference product dosed in first period followed by Topiramate Tablets, 2 x 25 mg test product dosed in second period
Period 1 STARTED	15	15
Period 1 COMPLETED	15	14
Period 1 NOT COMPLETED	0	1
Washout STARTED	15	14
Washout COMPLETED	14	14
Washout NOT COMPLETED	1	0
Period 2 STARTED	14	14
Period 2 COMPLETED	14	14
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Topiramate (Test) First Topiramate Tablets, 2 x 25 mg test product dosed in first period followed by Topomax® Tablets, 2 x 25 mg reference product dosed in second period.	Topamax® (Reference) First Topamax® Tablets, 2 x 25 mg reference product dosed in first period followed by Topiramate Tablets, 2 x 25 mg test product dosed in second period
Period 1 Adverse Event	0	1
Washout Withdrawal by Subject	1	0

Baseline Characteristics

Topiramate 25 mg Tablets Under Fasting Conditions

Baseline characteristics by cohort

Measure	Topiramate (Test) First n=15 Participants Topiramate Tablets, 2 x 25 mg test product, dosed in first period followed by Topomax® Tablets, 2 x 25 mg reference product, dosed in second period	Topamax® (Reference) First n=15 Participants Topamax® Tablets, 2 x 25 mg reference product, dosed in first period followed by Topiramate Tablets, 2 x 25 mg test product, dosed in second period	Total n=30 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	15 Participants n=5 Participants	15 Participants n=7 Participants	30 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	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	14 Participants n=5 Participants	15 Participants n=7 Participants	29 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	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 96 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=28 Participants Topiramate Tablets, 2 x 25 mg	Topomax® (Reference) n=28 Participants Topamax® Tablets, 2 x 25 mg
Cmax - Maximum Observed Concentration	830.39 ng/mL Standard Deviation 353.35	880.78 ng/mL Standard Deviation 342.30

PRIMARY outcome

Timeframe: Blood samples collected over 96 hour period

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

Bioequivalence based on AUC0-72

Outcome measures

Measure	Topiramate (Test) n=28 Participants Topiramate Tablets, 2 x 25 mg	Topomax® (Reference) n=28 Participants Topamax® Tablets, 2 x 25 mg
AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours (Per Participant)	21802.82 ng*hr/mL Standard Deviation 8341.74	21843.85 ng*hr/mL Standard Deviation 6622.16

PRIMARY outcome

Timeframe: Blood samples collected over 96 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=28 Participants Topiramate Tablets, 2 x 25 mg	Topomax® (Reference) n=28 Participants Topamax® Tablets, 2 x 25 mg
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)	25087.44 ng*hr/mL Standard Deviation 9071.31	25257.37 ng*hr/mL Standard Deviation 7483.58

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