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

Sandoz

Status and phase: Completed; Phase 1

Conditions: Infection

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00866216

AA02511

Details and patient eligibility

About

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

Enrollment: 38 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

1

Experimental group

Description:

Azithromycin Monohydrate 600mg Tablets

Treatment:

Drug: Azithromycin Monohydrate 600mg Tablets Geneva Pharmaceuticals

2

Active Comparator group

Description:

Zithromax (Azithromycin Dihydrate) 600mg Tablets

Treatment:

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