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

NCT ID: NCT00875966

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

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2004-10-31

Brief Summary

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

Detailed Description

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Conditions

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Infections

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 for oral suspension 200mg/5mL

Group Type EXPERIMENTAL

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

Intervention Type DRUG

2

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Interventions

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

Intervention Type DRUG

Zithromax (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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 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.

Other Identifiers

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AA17045

Identifier Type: -

Identifier Source: org_study_id

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