NCT01790165

TDT 067 Open Label Multi-Dose Onychomycosis Study

A Phase II Open Label Multiple-Dose Study of the Safety and Pharmacokinetics of TDT 067 Under Conditions of Maximal Use in Subjects With Distal Subungual Onychomycosis of the Toenails

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Celtic Pharma Development Services · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	TDT067 and Lamisil	Topical administration of TDT067 and single oral administration of 250 mg Lamisil tablet

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-01-01
• Completion: 2012-06-01
• First posted: 2013-02-13
• Last updated: 2013-02-13