An Open Label, Randomized, Crossover Study To Estimate The Pharmacokinetics And Evaluate The Safety Following A Single Dose Of Azithromycin 2g Extended-Release Powder For Oral Suspension With A 3-Day Dosing Regimen Of Azithromycin 500mg Tablet In Chinese Healthy Male Subjects

June 11, 2010 updated by: Pfizer
The purpose of this study is to estimate the pharmacokinetics and evaluate the safety following a single dose of azithromycin 2g extended-release powder for oral suspension with a 3-day dosing regimen of azithromycin 500mg tablet in Chinese healthy male subjects. This study data will be used to support azithromycin NDA in China.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200040
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy volunteers.
  • Male.
  • 18-45 years old.
  • BMI 17.5-30.5 kg/m2.

Exclusion Criteria:

  • Alcohol, drug, smoke user.
  • Sensitive to macrolide antibiotics class drug, parn or heparin-induced thrombocytopenia.
  • Severe medical or psychiatric condition or laboratory abnormality.
  • Blood donation.
  • 12-ECG abnormal.
  • Treatment with study drug; clinically significant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group 1
Will accept azithromycin ER first, after at least 14 days washout, then accept azithromycin tablet.
Drug: azithromycin (Zithromax)
  1. a single dose of azithromycin ER 2g
  2. 3-day regimen of azithromycin tablet 500mg
Other Names:
  • Zithromax
Drug: azithromycin (Zithromax)
  1. 3-day regimen of azithromycin tablet 500mg
  2. a single dose of azithromycin ER 2g
Other Names:
  • Zithromax
Other: Group 2
Will accept azithromycin tablet first, after at least 14 days washout, then accept azithromycin ER .
Drug: azithromycin (Zithromax)
  1. a single dose of azithromycin ER 2g
  2. 3-day regimen of azithromycin tablet 500mg
Other Names:
  • Zithromax
Drug: azithromycin (Zithromax)
  1. 3-day regimen of azithromycin tablet 500mg
  2. a single dose of azithromycin ER 2g
Other Names:
  • Zithromax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUC inf (if data permit) and AUC last of azithromycin
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
AUC 24, Cmax, Tmax, t1/2 of azithromycin
Time Frame: 2 months
2 months
vital signs, 12-lead ECG, laboratory tests and adverse events.
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

April 10, 2009

First Submitted That Met QC Criteria

April 10, 2009

First Posted (Estimate)

April 13, 2009

Study Record Updates

Last Update Posted (Estimate)

June 14, 2010

Last Update Submitted That Met QC Criteria

June 11, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0661179

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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