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

Information source: Mylan Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Topiramate Sprinkle Capsules 25 mg (Drug); Topamax® Sprinkle Capsules 25 mg (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Mylan Pharmaceuticals

Official(s) and/or principal investigator(s):
Dorian Williams, M.D., Principal Investigator, Affiliation: Kendle International Inc.

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.

Clinical Details

Official title: Single-Dose Fasting Bioequivalence Study of Topiramate Sprinkle Capsules (25 mg; Mylan) and Topamax Sprinkle Capsules (25 mg; Ortho-McNeil Neurologics) in Healthy Volunteers Dosed With Applesauce

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 and Contacts

Kendle International Inc., Morgantown, West Virginia 26505, United States
Additional Information

Mylan Pharmaceuticals Inc. - Clinical Trial Results

Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use

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Medwatch, FDA Safety Information and Adverse Event Reporting Program

Starting date: November 2005
Last updated: November 23, 2009

Page last updated: August 23, 2015

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