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

Phase 1CompletedNCT00865670

Sandoz38 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Infection

Interventions

Azithromycin Monohydrate 600 mg TabletsDRUG

Zithromax (azithromycin dihydrate) 600 mg TabletsDRUG

Eligibility

Sex: ALLMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Bioequivalence according to US FDA guidelines

Time frame: 32 days

Data from ClinicalTrials.gov

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