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Fed Study of Terbinafine Hydrochloride Tablets 250 mg and Lamisil® 250 mg

NCT00648713 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-04-23

No results posted yet for this study

Summary

The objective of this study was to investigate the bioequivalence of Mylan's terbinafine hydrochloride tablets to Novartis' Lamisil® tablets following a single, oral 250 mg (1 x 250 mg) dose administered under fed conditions.

Conditions

  • Healthy

Interventions

DRUG

Terbinafine Hydrochloride Tablets 250 mg

250mg, single dose fed

DRUG

Lamisil® Tablets 250 mg

250mg, single dose fed

Sponsors & Collaborators

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • James D Carlson, Pharm. D. · PRACS Institute Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2004-03-31
Completion
2004-03-31

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 NCT00648713 on ClinicalTrials.gov