NCT03929861

Bioequivalence Trial to Prove Equal Blood Concentrations of Two Different Fluconazole Formulations

An Open-label, Randomized, Two-treatment, Two-period, Two-sequence, Cross-over, Mono-center Bioequivalence Study to Compare Single Doses of Fluconazole 150 mg Capsule (Test Product) With Diflucan™ Capsule 150 mg (Reference) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Detailed description

Clinical pharmacology

Conditions

• Pharmacology, Clinical

Interventions

Type	Name	Description
DRUG	Fluconazole (BAYT006267) 150 mg capsules	Fluconazole 150 mg
DRUG	Fluconazole 150 mg capsules (DiflucanTM)	Fluconazole 150 mg

Timeline

• Start date: 2012-07-31
• Primary completion: 2012-09-10
• Completion: 2012-09-10
• First posted: 2019-04-29
• Last updated: 2019-04-29

Locations

1 site across 1 country: Germany