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

NCT03353480 | Completed Phase 1 FDA Drug

• 1 other identifier: A0661212
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bioequivalence

Keywords

Azithromycin tablet, Bioequivalence, Phase I, Chinese, Healthy Subjects

Outcome Measures

Primary Outcomes (2)

• AUC0-72

  Area under the serum concentration-time profile from time zero to 72 hours post dose based on observed serum concentrations at time points 0 (prior-dose), 0.5, 1, 2, 3, 4, 5, 6,8, 10, 12, 24, 48 and 72 hours after dose using linear/log trapezoidal methods

  0-72 hours

• Cmax

  Maximum serum concentration among observed serum concentrations at time points 0 (prior-dose), 0.5, 1, 2, 3, 4, 5, 6,8, 10, 12, 24, 48 and 72 hours after dose

  0-72 hours

Secondary Outcomes (1)

• Adverse Events

  Day 1 to Day 32 or early termination, plus at least 28 calendar days and up to 35 calendar days after the last administration of the investigational product

Study Arms (2)

Reference

OTHER

250mg Azithromycin tablet manufactured at Pfizer Barceloneta, Puerto Rico, US

Drug: Azithromycin Tablet manufactured in US

Experimental

EXPERIMENTAL

250mg Azithromycin tablet manufactured at Pfizer Dalian, China

Drug: Azithromycin Tablet manufactured in China

Interventions

Azithromycin Tablet manufactured in China DRUG

250 mg Azithromycin Tablet manufactured in China

Also known as: The localized originator, Experimental

Experimental

Azithromycin Tablet manufactured in US DRUG

250 mg Azithromycin Tablet manufactured in US

Also known as: The originator, Reference

Reference

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Chinese male and female subjects, between the ages of 18 and 45 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure (BP) and pulse rate (PR) measurement, 12-lead ECG, or clinical laboratory tests.
• BMI of 18 to 28 kg/m2; and a total body weight ≥50 kg for males and ≥45 kg for females.
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
• Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Subjects must be of Chinese ethnicity (individuals currently residing in mainland China who were born in China and have both parents of Chinese descent).

You may not qualify if:

• Subjects with any of the following characteristics/conditions will not be included in the study:
• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
• Any condition possibly affecting drug absorption (eg, gastrectomy).
• A positive urine drug screen, history of drug abuse within the past 5 years.
• History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 100 mL of wine or 285 mL of beer or 25 mL of hard liquor) within 3 months of Screening.
• Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day within 3 months prior to Screening.
• Treatment with an investigational drug within 3 months preceding the first dose of investigational product.
• Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the subject's eligibility.
• Screening supine 12-lead ECG demonstrating a corrected QT (QTc) interval \>450 msec or a QRS complex \>120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the subject's eligibility.
• Female subjects of childbearing potential and fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
• Female subjects who are breastfeeding or with positive pregnancy test at Screening and during the study period.
• Use of prescription or nonprescription drugs, dietary supplements and herbal medicines within 14 days prior to Screening. As an exception, acetaminophen/paracetamol may be used at doses of ≤1 g/day. Limited use of nonprescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case by case basis following approval by the sponsor. Taking any medicinal product that changes the activity of hepatic enzymes within 28 days prior to Screening, such as a strong CYP3A4 inducer (eg, St. John's Wort).
• Blood donation (excluding plasma donations) or loss of blood of approximately 450 mL or more within 3 months prior to Screening.
• History of hypersensitivity to azithromycin or any components of its formulation.
• Use of special diet (including dragon fruit, mango, citrus, etc.), strenuous activities or other factors that may affect the disposition of the study medication within 14 days prior to Screening.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

The First Hospital of Jilin University/Phase I Clinical Trials Unit

Changchun, Jilin, 130021, China

Location

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: November 27, 2017
• Study Start: December 20, 2017
• Primary Completion: January 29, 2018
• Study Completion: February 26, 2018
• Last Updated: February 21, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)