Comparative Bioavailability Study of Azithromycin 200mg/5mL Suspension Following a 600mg Dose Under Fed Conditions

Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of Eon and Pfizer Inc. (ZITHROMAX) 200mg/5mL Azithromycin Suspension Following a 600mg Dose in Healthy Adult Volunteers Under Fed Conditions

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00875966

Enrollment

Registered

2009-04-06

Start date

2004-08-31

Completion date

2004-10-31

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

Infections

Brief summary

The purpose of this study is to demonstrate the bioequivalence of Azithromycin 200mg/5mL oral suspension.

Interventions

DRUGAzithromycin for Oral Suspension 200mg/5mL Eon Pharma, LLC

DRUGZithromax (azithromycin for oral suspension) 200mg/5mL Pfizer

Subjects randomized to Zithromax received a single oral dose of Zithromax 600mg (15mL), administered with 240mL of water under fed conditions

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* No clinically significant findings on physical exam, medial history or laboratory tests on screening

Exclusion criteria

* Positive test for HIV or hepatitis B and C * Treatment for Drug or alcohol abuse * Any other important criteria in the protocol

Design outcomes

Primary

Measure	Time frame
Bioequivalence based on AUC and Cmax	37 days

Outcome results

None listed

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