Bioequivalency Study of Terbinafine Tablets Under Fasting Conditions - Full Text View

Sponsored by:	Roxane Laboratories
Information provided by:	Roxane Laboratories
ClinicalTrials.gov Identifier:	NCT00602342

Purpose

The objective of this study was the bioequivalence of a Roxane Laboratories' terbinafine tablets, 250 mg, to Lamisil® Tablets, 250 mg (Novartis Pharmaceutical Corporation.) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

Condition	Intervention
Onychomycosis	Drug: Terbinafine

Drug Information available for: Terbinafine Terbinafine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title:	A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of 250 mg Terbinafine Hydrochloride Tablets Under Fasting Conditions

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:

Bioequivalence [ Time Frame: Baseline, Two period, Twenty-one day washout ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	March 2004
Study Completion Date:	April 2004
Primary Completion Date:	April 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

Positive test for HIV, Hepatitis B, or Hepatitis C.
Treatment with known enzyme altering drugs.
History of allergic or adverse response to terbinafine or any comparable or similar product.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00602342

Locations

United States, Missouri
Gateway Medical Research, Inc.
St. Charles, Missouri, United States, 63301

Sponsors and Collaborators

Roxane Laboratories

Investigators

Principal Investigator:

Steven Herrmann, MD

Cetero Research

More Information

Responsible Party:	Roxane Laboratories, Inc, ( Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs )
Study ID Numbers:	TERB-01
Study First Received:	January 15, 2008
Last Updated:	February 5, 2008
ClinicalTrials.gov Identifier:	NCT00602342
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Mycoses
Skin Diseases, Infectious
Onychomycosis
Skin Diseases
Clotrimazole

Miconazole
Tioconazole
Tinea
Terbinafine
Dermatomycoses

Additional relevant MeSH terms:

Anti-Infective Agents
Nail Diseases
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Antifungal Agents
Enzyme Inhibitors
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009