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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00866216

Enrollment

Registered

2009-03-20

Start date

2003-08-31

Completion date

2003-09-30

Last updated

2017-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection

Brief summary

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

Interventions

DRUGAzithromycin Monohydrate 600mg Tablets Geneva Pharmaceuticals

DRUGZithromax (Azithromycin Dihydrate) 600mg Tablets Pfizer Inc.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Bioequivalence based on AUC and Cmax	32 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026