To Demonstrate the Relative Bioavailability of Azithromycin 600 mg Tablets Under Fed Conditions

March 27, 2017 updated by: Sandoz

Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Geneva 600 mg Azithromycin Monohydrate Tablets and Pfizer Inc. (Zithromax) 600 mg Azithromycin Dihydrate Tablets in Healthy Adult Volunteers Under Fed Conditions

To demonstrate the bioequivalence of Azithromycin 600 mg Tablets Under Fed Conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 1

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

19 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening

Exclusion Criteria:

  • Positive test results for HIV or hepatitis B or C
  • Treatment for drug or alcohol dependence
  • Female subjects who are pregnant or lactating

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Azithromycin Monohydrate 600mg Tablets
Drug: Azithromycin Monohydrate 600 mg Tablets
Active Comparator: 2
Zithromax (azithromycin dihydrate)600mg Tablets
Drug: Zithromax (azithromycin dihydrate) 600 mg Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bioequivalence according to US FDA guidelines
Time Frame: 32 days
32 days

Collaborators and Investigators

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

Sponsor

Sandoz

Investigators

  • Principal Investigator: Alan S. Marion, M.D., MDS Pharma Services

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

August 1, 2003

Primary Completion (Actual)

September 1, 2003

Study Completion (Actual)

September 1, 2003

Study Registration Dates

First Submitted

March 18, 2009

First Submitted That Met QC Criteria

March 18, 2009

First Posted (Estimate)

March 19, 2009

Study Record Updates

Last Update Posted (Actual)

March 29, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AA03414

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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