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

Sandoz

Status and phase: Completed; Phase 1

Conditions: Infections

Treatments: Drug: Azithromycin for Oral Suspension 200mg/5mL Eon Pharma, LLC; Drug: Zithromax (azithromycin for oral suspension) 200mg/5mL Pfizer

Study type: Interventional

Funder types: Industry

Identifiers

NCT00875966

AA17045

Details and patient eligibility

About

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

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

1

Experimental group

Description:

Azithromycin for oral suspension 200mg/5mL

Treatment:

Drug: Azithromycin for Oral Suspension 200mg/5mL Eon Pharma, LLC

2

Active Comparator group

Description:

Zithromax (azithromycin for oral suspension) 200mg/5mL

Treatment:

Drug: Zithromax (azithromycin for oral suspension) 200mg/5mL Pfizer