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Completed Phase 1 Interventional Accepts healthy volunteers Results available

Azithromycin 600 Mg Tablets, Fasting

ClinicalTrials.gov ID: NCT00834756

Public ClinicalTrials.gov record NCT00834756. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 2:07 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Two-Way Crossover, Single-Dose, Open-Label Study to Evaluate the Relative Bioavailability of a Test Tablet Formulation of Azithromycin (600 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Zithromax®, Pfizer, Inc.) in 36 Fasted, Healthy, Adult Subjects

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The objective of this randomized, single-dose, two-way crossover evaluation is to compare the relative bioequivalence of a test azithromycin formulation (TEVA Pharmaceuticals USA) to an equivalent oral dose of the commercially available azithromycin (Zithromax®, Pfizer, Inc.) in a test population of 36 adult subjects under fasting conditions.

Study identification

NCT ID
NCT00834756
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Teva Pharmaceuticals USA
Industry
Enrollment
36 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 31, 2002
Primary completion
Sep 30, 2002
Completion
Sep 30, 2002
Last update posted
Aug 18, 2024

2002

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Gateway Medical Research, Inc. Saint Charles Missouri 63301

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

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About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00834756, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 18, 2024 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00834756 live on ClinicalTrials.gov.

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