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

NCT ID: NCT00865670

Last Updated: 2017-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2003-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Azithromycin Monohydrate 600mg Tablets

Group Type EXPERIMENTAL

Azithromycin Monohydrate 600 mg Tablets

Intervention Type DRUG

2

Zithromax (azithromycin dihydrate)600mg Tablets

Group Type ACTIVE_COMPARATOR

Zithromax (azithromycin dihydrate) 600 mg Tablets

Intervention Type DRUG

Interventions

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Azithromycin Monohydrate 600 mg Tablets

Intervention Type DRUG

Zithromax (azithromycin dihydrate) 600 mg Tablets

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sandoz

INDUSTRY

Sponsor Role lead

Responsible Party

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Sandoz Inc.

Principal Investigators

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Alan S. Marion, M.D.

Role: PRINCIPAL_INVESTIGATOR

MDS Pharma Services

Other Identifiers

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AA03414

Identifier Type: -

Identifier Source: org_study_id

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