Applesauce Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg - Full Text View

Sponsor:	Mylan Pharmaceuticals
Information provided by:	Mylan Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00649467

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: Topiramate Sprinkle Capsules 25 mg Drug: Topamax® Sprinkle Capsules 25 mg	Phase I

Study Type:	Interventional
Study Design:	Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
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

Resource links provided by NLM:

Drug Information available for: Topiramate

U.S. FDA Resources

Further study details as provided by Mylan Pharmaceuticals:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	35
Study Start Date:	November 2005
Study Completion Date:	December 2005
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Topiramate Sprinkle Capsules 25 mg	Drug: Topiramate Sprinkle Capsules 25 mg 25mg, single dose applesauce
2: Active Comparator Topamax® Sprinkle Capsules 25 mg	Drug: Topamax® Sprinkle Capsules 25 mg 25mg, single dose applesauce

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00649467

Locations

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

Sponsors and Collaborators

Mylan Pharmaceuticals

Investigators

Principal Investigator:

Dorian Williams, M.D.

Kendle International Inc.

More Information

Additional Information:

Mylan Pharmaceuticals Inc. - Clinical Trial Results This link exits the ClinicalTrials.gov site

Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use This link exits the ClinicalTrials.gov site

Recalls, Market Withdrawals and Safety Alerts This link exits the ClinicalTrials.gov site

FDA Enforcement Report Index This link exits the ClinicalTrials.gov site

Medwatch, FDA Safety Information and Adverse Event Reporting Program This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Mylan Inc. ( Wayne Talton )
Study ID Numbers:	TOPR-0585
Study First Received:	March 30, 2008
Last Updated:	November 23, 2009
ClinicalTrials.gov Identifier:	NCT00649467 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anti-Obesity Agents
Therapeutic Uses
Physiological Effects of Drugs
Topiramate
Protective Agents

Neuroprotective Agents
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010