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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2005-12-31

Brief Summary

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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 administered under fasting conditions.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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1

Topiramate Sprinkle Capsules 25 mg

Group Type EXPERIMENTAL

Topiramate Sprinkle Capsules 25 mg

Intervention Type DRUG

25mg, single dose fasting

2

Topamax® Sprinkle Capsule 25 mg

Group Type ACTIVE_COMPARATOR

Topamax® Sprinkle Capsule 25 mg

Intervention Type DRUG

25mg, single dose fasting

Interventions

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Topiramate Sprinkle Capsules 25 mg

25mg, single dose fasting

Intervention Type DRUG

Topamax® Sprinkle Capsule 25 mg

25mg, single dose fasting

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes