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

Information source: Sandoz
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infection

Intervention: Azithromycin Monohydrate 600mg Tablets Geneva Pharmaceuticals (Drug); Zithromax (Azithromycin Dihydrate) 600mg Tablets Pfizer Inc. (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Sandoz Inc.

Official(s) and/or principal investigator(s):
Alan S Marion, Principal Investigator, Affiliation: MDS Pharma


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

Clinical Details

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Bioequivalence based on AUC and Cmax


Minimum age: 19 Years. Maximum age: 55 Years. Gender(s): Both.


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

Locations and Contacts

Additional Information

Starting date: August 2003
Last updated: March 19, 2009

Page last updated: August 23, 2015

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