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Terbinafine HCl 250 mg Tablet Formulations Under Non-Fasting Conditions

NCT00833664 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2023-05-30

Study results available
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Summary

The Purpose of this study os to evaluate the relative bioavailability of the test formulation of terbinafine tablets with an already marketed reference formulation Lamisil® (Novartis Pharmaceuticals), under post-prandial conditions in healthy, non-tobacco using male and female adult subjects.

Conditions

  • Healthy

Interventions

DRUG

Terbinafine HCl 250mg tablets

1 x 250 mg

DRUG

Lamisil® 250 mg Tablets

1 x 250 mg

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    lead INDUSTRY

Principal Investigators

  • Shirley Ann Kennedy, M.D. · Novum

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-01-31
Primary Completion
2002-01-31
Completion
2002-01-31

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 NCT00833664 on ClinicalTrials.gov