Bioequivalence (BE) Study Comparing Azithromycin 250 mg Tablet Manufactured in China and in the United States
Status:
Completed
Trial end date:
2018-02-26
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
reference scaled bioequivalence study to support the program and to demonstrate the
bioequivalence between the 250 mg azithromycin tablet manufactured at Pfizer Dalian, China
(the localized originator, Test) and the 250 mg azithromycin tablet manufactured at Pfizer
Barceloneta, Puerto Rico, US (the originator, Reference) in healthy Chinese subjects under
fasted and fed conditions. This open-lable, randomized, single-dose 3-way crossover study
will enroll approximately 33 subjects for each condition. The primary endpoints are
azithromycin area under the serum concentration-time curve from time zero to 72 hours
post-dose (AUC72) and Cmax.