Overview

Study Comparing SUBA™-Itraconazole With SPORANOX® (Itraconazole) in the Treatment of Onychomycosis

Status:
Completed
Trial end date:
2010-12-01
Target enrollment:
Participant gender:
Summary
The objective of this study is to compare the relative efficacy and safety of SUBA™-Itraconazole Capsules (HalcyGen Ltd) to an already marketed oral formulation of itraconazole SPORANOX® (itraconazole) capsules (Janssen Pharma) in the treatment of onychomycosis of the toenail. Both the test and the reference formulations will also be compared to a placebo formulation to test for superiority.
Phase:
Phase 2
Details
Lead Sponsor:
Halcygen Pharmaceuticals Limited
Treatments:
Hydroxyitraconazole
Itraconazole