NCT01039883

A Study to Compare the Blood Levels of Albaconazole in Healthy Subjects Who Have Received a Single Dose of 400 mg Albaconazole as a Tablet Versus Albaconazole as a Capsule

A Phase 1, Randomized, Open-Label, Crossover Safety and Pharmacokinetic Study of 400 mg Albaconazole as a Tablet Formulation Versus a Capsule Formulation in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Stiefel, a GSK Company · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether albaconazole tablets and albaconazole capsules (single 400mg dose) act in the body in the same way over a period of time.

Detailed description

The aim of this study is to compare the bioavailability of the formulation used in earlier clinical studies (albaconazole capsules) with the formulation intended for use in further development (albaconazole tablets). The study is also designed to assess the safety and tolerability of a single oral dose of albaconazole tablets (400 mg), and assess the bioequivalence of albaconazole tablets with albaconazole capsules.

Conditions

• Onychomycosis

Interventions

Type	Name	Description
DRUG	Albaconazole tablet 400mg	Albaconazole tablet 400mg single dose, then four albaconazole capsule 100mg single dose
DRUG	Albaconazole 100mg capsules, then albaconazole 400mg tablet	Four albaconazole capsule 100mg single dose, then albaconazole tablet 400mg single dose

Timeline

• Start date: 2009-11-23
• Primary completion: 2010-01-20
• Completion: 2010-01-20
• First posted: 2009-12-25
• Last updated: 2017-06-22

Locations

1 site across 1 country: United States