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Bioequivalency Study of Terbinafine Tablets Under Fasting Conditions

NCT00602342 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-01-23

No results posted yet for this study

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.

Conditions

  • Onychomycosis

Interventions

DRUG

Terbinafine

Sponsors & Collaborators

  • Roxane Laboratories

    lead INDUSTRY

Principal Investigators

  • Steven Herrmann, MD · Cetero Research, San Antonio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2004-04-30
Completion
2004-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00602342 on ClinicalTrials.gov