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Safety and Pharmacokinetics of Terbinafine Hydrogen Chloride (HCl) Nail Lacquer in Patients With Onychomycosis

NCT00691184 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2008-06-05

No results posted yet for this study

Summary

In this study, the safety and pharmacokinetics of 10 % terbinafine hydrogen chloride (HCl) nail lacquer wre investigated by comparison with vehicle control and 1% terbinafine cream

Conditions

  • Onychomycosis/Onycholysis and Tinea Pedis

Interventions

DRUG

Placebo

0% Terbinafine HCl Nail Lacquer for onychomycosis, twice daily for 28 days.

DRUG

Terbinafine Hydrochloride

10% Terbinafine HCl Nail Lacquer for onychomycosis, twice daily for 28 days.

DRUG

Terbinafine Hydrochloride

1% Terbinafine Hydrochloride Cream, twice a day for 7 days.

DRUG

Terbinafine

Terbinafine tablet, 250mg, single dose in groups 1,2 and 3 at end of study.

Sponsors & Collaborators

  • NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)

    lead INDUSTRY

Principal Investigators

  • Ming Q Lu, MD., Ph.D. · NexMed (U.S.A.), Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2005-06-30
Completion
2005-12-31

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT00691184 on ClinicalTrials.gov