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TDT 067 Open Label Multi-Dose Onychomycosis Study

NCT01790165 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2013-02-13

No results posted yet for this study

Summary

The aim of this study is to establish a clinical bridge to Lamisil® tablets by conducting a clinical pharmacokinetic (PK) study comparing the systemic exposure of a Lamisil® tablet with that of with TDT 067 under maximal use conditions.

Under maximal use conditions in onychomycotic subjects, the aim is to confirm that there are significantly lower plasma levels of terbinafine and its major metabolites after a topical administration of TDT 067 for 28 days in comparison with a single oral 250 mg Lamisil® tablet.

Conditions

  • Onychomycosis

Interventions

DRUG

TDT067 and Lamisil

Topical administration of TDT067 and single oral administration of 250 mg Lamisil tablet

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • Celtic Pharma Development Services

    lead INDUSTRY

Principal Investigators

  • Eduardo Tschen, MD · Academic Dermatology Assoc

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-01-31
Completion
2012-06-30

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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 NCT01790165 on ClinicalTrials.gov