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

Mylan Pharmaceuticals Inc36 enrolled

Overview

The objective of this study was to investigate the bioequivalence of Mylan's topiramate sprinkle 25 mg capsules to Ortho-McNeil's Topamax® Sprinkle 25 mg capsules following a single, oral 25 mg (1 x 25 mg) dose administered under fed conditions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Topiramate Sprinkle Capsules 25 mgDRUG

25mg, single dose fed

Topamax® Sprinkle Capsules 25 mgDRUG

25mg, single dose fed

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Kendle International Inc.

Morgantown, West Virginia, United States

Outcomes

Primary Outcomes

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.

Time frame: blood collections through 144 hours

Data from ClinicalTrials.gov

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