NCT03353480

Bioequivalence (BE) Study Comparing Azithromycin 250 mg Tablet Manufactured in China and in the United States

AN OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, 3-WAY CROSSOVER BIOEQUIVALENCE STUDY COMPARING AZITHROMYCIN 250 MG TABLET (MANUFACTURED AT PFIZER DALIAN, CHINA) WITH AZITHROMYCIN 250 MG TABLET (MANUFACTURED AT PFIZER BARCELONETA, UNITED STATES) UNDER FASTED AND FED CONDITIONS IN HEALTHY CHINESE SUBJECTS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 45 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 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.

Detailed description

This is a reference scaled bioequivalence study to support a generic consistency evaluation program, initiated by CFDA in 2016, for the evaluation of quality and efficacy of the products manufactured in China. The selected strength of 250 mg tablet is the approved strength. The primary objective is 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 (Group 1) and fed (Group 2) conditions. Approximately 33 Chinese healthy subjects will be enrolled for each group. The primary endpoints are azithromycin area under the serum concentration-time curve from time zero to 72 hours post-dose (AUC72) and Cmax. The secondary objective is to evaluate the safety and tolerability of azithromycin administered as a single oral dose of 250 mg tablet manufactured at Pfizer Dalian, China and 250 mg tablet manufactured at Pfizer Barceloneta, Puerto Rico, US in healthy Chinese subjects under fasted and fed conditions. And the secondary endpoint is adverse events (AEs). Other endpoints include Tmax of azithromycin, safety laboratory tests and vital signs. In each group, subjects will be randomized to one of the 3 treatment sequences. Each treatment sequence will consist of 3 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 azithromycin in serum will be collected at pre-dose (within 30 minutes prior to dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 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	Azithromycin Tablet manufactured in China	250 mg Azithromycin Tablet manufactured in China
DRUG	Azithromycin Tablet manufactured in US	250 mg Azithromycin Tablet manufactured in US

Timeline

• Start date: 2017-12-20
• Primary completion: 2018-01-29
• Completion: 2018-02-26
• First posted: 2017-11-27
• Last updated: 2019-02-21

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study