Applesauce Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Topiramate Sprinkle Capsules 25 mg; Drug: Topamax® Sprinkle Capsules 25 mg

• Registration Number: NCT00649467
• Lead Sponsor: Mylan Pharmaceuticals Inc

Brief Summary

The objective of this study was to investigate the bioequivalence of Mylan's topiramate sprinkle 25 mg capsule to Ortho-McNeil's Topamax® Sprinkle 25 mg capsule following a single, oral 25 mg (1 x 25 mg) dose sprinkled on one teaspoon of applesauce under fasting conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Study First Submitted: 2008-03-30
• Study First Submitted QC: 2008-03-31
• Study First Posted: 2008-04-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• healthy, adult subjects, 18 years and older
• able to swallow medication

Exclusion Criteria

• institutionalized subjects
• history of any significant disease
• use of any prescription or OTC medications within 14 days of start of study
• received any investigational products within 30 days prior to start of study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Topiramate Sprinkle Capsules 25 mg	Topiramate Sprinkle Capsules 25 mg
2	Topamax® Sprinkle Capsules 25 mg	Topamax® Sprinkle Capsules 25 mg

Primary Outcome Measures

Name	Time	Method
The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.	blood collections through 144 hours

Trial Locations

Locations (1)

Kendle International Inc.; 🇺🇸 Morgantown, West Virginia, United States