Bioequivalence (BE) Study Comparing Azithromycin 250 mg Tablet Manufactured in China and in the United States
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Azithromycin Tablet manufactured in China; Azithromycin Tablet manufactured in US
Intervention type(s): Drug; Drug
Intervention description(s): 250 mg Azithromycin Tablet manufactured in China; 250 mg Azithromycin Tablet manufactured in US
Other intervention name(s): The localized originator, Experimental; The originator, Reference
Intervention MeSH terms: Azithromycin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is an open-label, randomized, single-dose, 3-way crossover, reference scaled bioequivalence study under fasted and fed conditions in healthy Chinese subjects.
Under each condition, 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. For sequence 1, first localized originator, then originator and finally originator will be administered. The order for sequence 2 is originator, localized originator and originator. The order for sequence 3 is originator, originator and localized originator.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Azithromycin tablet, Bioequivalence, Phase I, Chinese, Healthy Subjects