Overview

Single Dose Crossover Comparative Bioavailability Study of Two Formulations of Fluconazole 200 mg in Healthy Adult Subjects Under Fasting Conditions

Status:
Unknown status

Trial end date:
2019-09-01

Target enrollment:

Participant gender:

Summary

This single dose study is designed in accordance with EMA (the European Medicines Agency) regulatory guidelines, with the aim of characterizing the comparative bioavailability of fluconazole in the two formulations in healthy subjects. As this is a bioequivalence trial where each subject will receive each study treatment in a crossover fashion, a control group is not included. Within the clinical portion of the study each subject will receive a single oral dose of the test and the reference formulation in compliance with the generated randomization code. The primary study endpoints are the pharmacokinetic (PK) parameters Cmax and AUC0-t of fluconazole.

Phase:

Phase 1

Details

Lead Sponsor:

Pharmtechnology LLC

Collaborators:

Altasciences Company Inc.
Altasciences Company, Inc.

Treatments:

Fluconazole