Bioequivalence (BE) Study Comparing Fluconazole 150mg Capsule Manufactured in China and in France
Status:
Completed
Trial end date:
2019-07-20
Target enrollment:
Participant gender:
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.