NCT03621072

Bioequivalence (BE) Study Comparing Fluconazole 150mg Capsule Manufactured in China and in France

AN OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, 2-WAY CROSSOVER BIOEQUIVALENCE STUDY COMPARING FLUCONAZOLE 150 MG CAPSULE (MANUFACTURED AT PFIZER DALIAN, CHINA) WITH FLUCONAZOLE 150 MG CAPSULE (MANUFACTURED AT PFIZER FAREVA, AMBOISE, FRANCE) UNDER FASTED AND FED CONDITIONS IN HEALTHY CHINESE SUBJECTS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

China Food and Drug Administration (CFDA) initiated a generic consistency evaluation program to evaluate the quality and efficacy of the products manufactured in China in 2016. This is a bioequivalence study to support the program and to demonstrate the bioequivalence between the 150 mg fluconazole capsule manufactured at Pfizer Dalian, China (the localized originator, Test) and the 150 mg fluconazole capsule manufactured at Pfizer Fareva, Amboise, France (the originator, Reference) in healthy Chinese subjects under fasted and fed conditions. This open-lable, randomized, single-dose 2-way crossover study will enroll approximately 18 subjects for each condition. The primary endpoints are fluconazole area under the plasma concentration-time curve from time zero to 72 hours post-dose (AUC72) and Cmax.

Detailed description

This trial is a bioequivalence study to support a generic consistency evaluation program, initiated by the China Food and Drug Administration (CFDA), for the evaluation of quality and efficacy of the products manufactured in China. The selected strength of 150 mg capsule is the approved highest strength of capsule formulation in China. The 150 mg dose was selected for evaluation in this study as it is one of the commonly used clinically approved doses. The primary objective is to demonstrate the bioequivalence between the 150 mg fluconazole capsule manufactured at Pfizer Dalian, China (the localized originator, Test) and the 150 mg fluconazole capsule manufactured at Pfizer Fareva, Amboise, France (the originator, Reference) administered as a single oral dose in healthy Chinese subjects under fasted and fed conditions. The primary endpoints are fluconazole area under the plasma concentration-time curve from time zero to 72 hours post-dose (AUC72) and peak plasma concentrations (Cmax). The secondary objective is to evaluate the safety and tolerability of fluconazole administered as a single oral dose of 150 mg capsule manufactured at Pfizer Dalian, China and 150 mg capsule manufactured at Pfizer Fareva, Amboise, France in healthy Chinese subjects under fasted and fed conditions. The secondary endpoint is adverse events (AEs). Other endpoints include time to reach Cmax (Tmax) of fluconazole, safety laboratory tests and vital signs. In each group, subjects will be randomized to one of the 2 treatment sequences. Each treatment sequence will consist of 2 periods, separated by a washout period of at least 14 days between each period. On Day 1 of each period in both groups, each subject will be administered investigational product at approximately 8:00 AM (± 2 hours). Blood samples for the analysis of fluconazole in plasma will be collected at pre-dose (within 1 hour prior to dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48 and 72 hours post dose in each period. Vital signs, physical examination, laboratory tests and 12 lead electrocardiogram (ECG) will be performed at specified times. Tolerability and safety will be assessed for all treatments by monitoring AEs.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	Fluconazole 150mg Capsule Originator	150mg fluconazole capsule (originator) manufactured at Pfizer Fareva, Amboise, France
DRUG	Fluconazole 150mg Capsule Localized Originator	150mg Fluconazole capsule (localized originator) manufactured at Pfizer, Dalian, China

Timeline

• Start date: 2019-06-03
• Primary completion: 2019-07-20
• Completion: 2019-07-20
• First posted: 2018-08-08
• Last updated: 2021-07-16

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study