Trial Outcomes & Findings for Topiramate 25 mg Capsule Mixed With Applesauce Under Fasting Conditions (NCT NCT00905346)

NCT ID: NCT00905346

Last Updated: 2024-08-20

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: 2024-08-20

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	12	12
Period 1 COMPLETED	11	12
Period 1 NOT COMPLETED	1	0
Period 2 STARTED	10	11
Period 2 COMPLETED	10	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 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 Withdrawal by Subject	1	0

Baseline Characteristics

Topiramate 25 mg Capsule Mixed With Applesauce 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	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	11 Participants n=7 Participants	21 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 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=21 Participants Topiramate Capsules 2 x 25 mg dosed in either period	Topamax® Reference n=21 Participants Topamax® 2 x 25 mg Capsule dosed in either period
Cmax - Maximum Observed Concentration	630.45 ng/mL Standard Deviation 165.68	631.49 ng/mL Standard Deviation 158.97

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=21 Participants Topiramate Capsules 2 x 25 mg dosed in either period	Topamax® Reference n=21 Participants Topamax® 2 x 25 mg Capsule dosed in either period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	33225.68 ng*hr/mL Standard Deviation 5455.22	32576.20 ng*hr/mL Standard Deviation 8063.83

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=21 Participants Topiramate Capsules 2 x 25 mg dosed in either period	Topamax® Reference n=21 Participants Topamax® 2 x 25 mg Capsule dosed in either period
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration	28199.89 ng*hr/mL Standard Deviation 4966.86	27731.63 ng*hr/mL Standard Deviation 7139.70

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