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

Mylan

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Topamax® Sprinkle Capsule 25 mg; Drug: Topiramate Sprinkle Capsules 25 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00649740

TOPR-0583

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

1

Experimental group

Description:

Topiramate Sprinkle Capsules 25 mg

Treatment:

Drug: Topiramate Sprinkle Capsules 25 mg

2

Active Comparator group

Description:

Topamax® Sprinkle Capsule 25 mg

Treatment:

Drug: Topamax® Sprinkle Capsule 25 mg