Bioequivalence Trial to Prove Equal Blood Concentrations of Two Different Fluconazole Formulations
Status:
Completed
Trial end date:
2012-09-10
Target enrollment:
Participant gender:
Summary
Primary Objective: To compare the bioavailability of a single dose of fluconazole 150 mg
capsules (Test product) with the bioavailability of a single dose of Diflucan™ capsules, 150
mg (Reference) administered under fasting conditions in order to assess bioequivalence
Secondary Objectives: To assess safety and tolerability in form of adverse events and
clinical parameters (systolic/diastolic blood pressure, pulse rate, body temperature,
physical examination, electrocardiogram, clinical laboratory testing, and overall
tolerability) and to assess further pharmacokinetic parameters of fluconazole