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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00865670

Enrollment

Registered

2009-03-19

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

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

Interventions

DRUGAzithromycin Monohydrate 600 mg Tablets

DRUGZithromax (azithromycin dihydrate) 600 mg Tablets

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 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

Design outcomes

Primary

Measure	Time frame
Bioequivalence according to US FDA guidelines	32 days

Outcome results

None listed

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