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

This study has been completed.

Sponsor:

Information provided by:

Sandoz

ClinicalTrials.gov Identifier:

NCT00866216

First received: March 18, 2009

Last updated: March 19, 2009

Last verified: March 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

March 18, 2009

Last Updated Date

March 19, 2009

Start Date ^ICMJE

August 2003

Primary Completion Date

September 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Bioequivalence based on AUC and Cmax [ Time Frame: 32 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00866216 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Infection

Intervention ^ICMJE

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

Study Arm (s)

Experimental: 1
Azithromycin Monohydrate 600mg Tablets

Intervention: Drug: Azithromycin Monohydrate 600mg Tablets Geneva Pharmaceuticals
Active Comparator: 2
Zithromax (Azithromycin Dihydrate) 600mg Tablets

Intervention: Drug: Zithromax (Azithromycin Dihydrate) 600mg Tablets Pfizer Inc.

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2003

Primary Completion Date

September 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

19 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT Number ^ICMJE

NCT00866216

Other Study ID Numbers ^ICMJE

AA02511

Has Data Monitoring Committee

Responsible Party

Eric Mittleberg, Ph.D., VP Product Development, Sandoz Inc.

Study Sponsor ^ICMJE

Sandoz Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Alan S Marion

MDS Pharma

Information Provided By

Sandoz

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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