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Clinical Trials/NCT00602342
NCT00602342CompletedNot Applicable

A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of 250 mg Terbinafine Hydrochloride Tablets Under Fasting Conditions

Roxane Laboratories1 site in 1 country30 target enrollmentStarted: March 1, 2004Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
Bioequivalence
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Bioequivalence

Time Frame: Baseline, Two period, Twenty-one day washout

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry

Study Sites (1)

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