Comparative Bioavailability Study of 600mg Azithromycin Monohydrate Tablets Under Fasting Conditions

The purpose of this study is to demonstrate the bioequivalence of Azithromycin Monohydrate 600 mg Tablets.

Completed

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Key information

Conditions

Infection Infections

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

No clinically significant abnormal findings 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

Treatment and study plan

Azithromycin Monohydrate 600mg Tablets Geneva Pharmaceuticals

Drug

Zithromax (Azithromycin Dihydrate) 600mg Tablets Pfizer Inc.

Drug

Primary outcomes

Bioequivalence based on AUC and Cmax

Time frame: 32 days

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Official study title

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

Important dates

Study start: 2003
Primary completion: 2003
Study completion: 2003
First posted: Mar 20, 2009
Registry last updated: Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed