Trial Outcomes & Findings for Topiramate 25 mg Tablets Under Fed Conditions (NCT NCT00905567)

NCT ID: NCT00905567

Last Updated: 2009-09-23

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 24 participants
• Primary outcome timeframe: Blood samples collected over 96 hour period
• Results posted on: 2009-09-23

Participant Flow

Participant milestones

Measure	Topiramate (Test) First Topiramate 2 x 25 mg Tablet (test)dosed in first period followed by Topamax® 2 x 25 mg Tablet (reference) dosed in second period	Topamax® (Reference) First Topamax® Tablet 2 x 25 mg (reference) dosed in first period followed by Topiramate 2 x 25 mg Tablet (test) dosed in second period
Period 1 STARTED	12	12
Period 1 COMPLETED	12	12
Period 1 NOT COMPLETED	0	0
Washout STARTED	12	12
Washout COMPLETED	12	11
Washout 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 2 x 25 mg Tablet (test)dosed in first period followed by Topamax® 2 x 25 mg Tablet (reference) dosed in second period	Topamax® (Reference) First Topamax® Tablet 2 x 25 mg (reference) dosed in first period followed by Topiramate 2 x 25 mg Tablet (test) dosed in second period
Washout Withdrawal by Subject	0	1

Baseline Characteristics

Topiramate 25 mg Tablets Under Fed Conditions

Baseline characteristics by cohort

Measure	Topiramate (Test) First n=12 Participants Topiramate 2 x 25 mg Tablet (test)dosed in first period followed by Topamax® 2 x 25 mg Tablet (reference) dosed in second period	Topamax® (Reference) First n=12 Participants Topamax® Tablet 2 x 25 mg (reference) dosed in first period followed by Topiramate 2 x 25 mg Tablet (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	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	12 Participants n=5 Participants	12 Participants n=7 Participants	24 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 96 hour period

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

Bioequivalence based on Cmax

Outcome measures

Measure	Topiramate n=23 Participants Topiramate 2 x 25 mg Tablet	Topamax® n=23 Participants Topamax® Tablet 2 x 25 mg
Cmax - Maximum Observed Concentration	633.96 ng/mL Standard Deviation 251.55	700.79 ng/mL Standard Deviation 310.12

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 n=23 Participants Topiramate 2 x 25 mg Tablet	Topamax® n=23 Participants Topamax® Tablet 2 x 25 mg
AUC0-72 - Area Under the Concentration Time Curve From Time Zero to Time 72 Hours (Per Participant)	20792.34 ng*hr/mL Standard Deviation 7701.94	21930.92 ng*hr/mL Standard Deviation 9118.60

PRIMARY outcome

Timeframe: Blood samples collected over 96 hour period

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

Bioequivalence based on AUC0-t

Outcome measures

Measure	Topiramate n=23 Participants Topiramate 2 x 25 mg Tablet	Topamax® n=23 Participants Topamax® Tablet 2 x 25 mg
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)	23634.03 ng*hr/mL Standard Deviation 8515.55	24918.64 ng*hr/mL Standard Deviation 9927.37

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