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

PHASE1CompletedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

February 28, 2005

Primary Completion Date

June 30, 2005

Study Completion Date

December 31, 2005

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.

Trial Locations (1)

07652

TKL Research Inc., Paramus

All Listed Sponsors
lead

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

INDUSTRY

NCT00691184 - Safety and Pharmacokinetics of Terbinafine Hydrogen Chloride (HCl) Nail Lacquer in Patients With Onychomycosis | Biotech Hunter | Biotech Hunter