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NCT00650273 · ClinicalTrials.gov registry record · Phase 1

Fasting Study of Azithromycin Tablets 600 mg to Zithromax® Tablets 600 mg

A Phase 1 study of Healthy, sponsored by Mylan Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
54
Enrollment target
1
Study location

NCT00650273: Completed Phase 1 study of Healthy, sponsored by Mylan Pharmaceuticals.

NCT00650273 is a Phase 1 study of Healthy that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 54 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00650273, a Phase 1 study of Healthy, has completed, sponsored by Mylan Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
54 participants
Enrollment target
1
Study location

Study Summary

The objective of this study was to investigate the bioequivalence of Mylan's azithromycin 600 mg tablets to Pfizer's Zithromax® 600 mg tablets following a single, oral 600 mg (1 x 600 mg) dose administered under fasting conditions.

Conditions Studied

Interventions

  • DRUG Azithromycin Tablets 600 mg
  • DRUG Zithromax® Tablets 600 mg

Study Locations (1)

West Virginia

  • Kendle International Inc. - Morgantown

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2005-04
Est. Completion 2005-05
Phase Phase 1
Mylan Pharmaceuticals

146 total trials

What the finished NCT00650273 record still lists

NCT00650273 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (92% lower).

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Azithromycin Tablets 600 mg is the first listed.

NCT00650273 reports a single indexed study location in West Virginia.

Frequently Asked Questions

What is clinical trial NCT00650273 about?

NCT00650273 is a clinical study titled "Fasting Study of Azithromycin Tablets 600 mg to Zithromax® Tablets 600 mg". The objective of this study was to investigate the bioequivalence of Mylan's azithromycin 600 mg tablets to Pfizer's Zithromax® 600 mg tablets following a single, oral 600 mg (1 x 600 mg) dose administered under fasting conditions.

What is the current status of trial NCT00650273?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2005-04. Estimated completion is 2005-05.

What conditions does trial NCT00650273 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT00650273?

The interventions under investigation include: Azithromycin Tablets 600 mg (DRUG), Zithromax® Tablets 600 mg (DRUG).

Who is sponsoring clinical trial NCT00650273?

This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00650273 being conducted?

This trial has 1 study location across West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Healthy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00650273's enrollment target sits among peer trials

54 433rd of 1090 higher than 653 of 1,090 other Healthy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00650273, the US trial registry maintained by the National Library of Medicine. NCT00650273 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.