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NCT00840411 · ClinicalTrials.gov registry record · Phase 1

Clarithromycin 500 mg Extended Release Tablets Under Fasting Conditions

A Phase 1 study of Healthy, sponsored by Teva Pharmaceuticals U.

Completed
Registry status
Phase 1
Development phase
66
Enrollment target
1
Study location

NCT00840411: Completed Phase 1 study of Healthy, sponsored by Teva Pharmaceuticals U.

NCT00840411 is a Phase 1 study of Healthy that has completed, run by Teva Pharmaceuticals U. The registered enrollment target is 66 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (90% 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

NCT00840411, a Phase 1 study of Healthy, has completed, sponsored by Teva Pharmaceuticals U.

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

Study Summary

The objective of this study is to compare the relative bioequivalence of a test clarithromycin extended release formulation to an equivalent oral dose of the commercially available extended release clarithromycin in a test population of 66 adult subjects under fasting conditions.

Primary Outcome

Bioequivalence based on Cmax

Conditions Studied

Interventions

  • DRUG Clarithromycin ER 500 mg tablets
  • DRUG BIAXIN® XL 500 mg tablets

Study Locations (1)

Missouri

  • Gateway Medical Research - Saint Charles

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2002-09
Est. Completion 2002-10
Phase Phase 1
Teva Pharmaceuticals U

19 total trials

What the finished NCT00840411 record still lists

NCT00840411 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (90% lower).

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Clarithromycin ER 500 mg tablets is the first listed.

NCT00840411 reports a single indexed study location in Missouri.

Frequently Asked Questions

What is clinical trial NCT00840411 about?

NCT00840411 is a clinical study titled "Clarithromycin 500 mg Extended Release Tablets Under Fasting Conditions". The objective of this study is to compare the relative bioequivalence of a test clarithromycin extended release formulation to an equivalent oral dose of the commercially available extended release clarithromycin in a test population of 66 adult subjects under fasting conditions.

What is the current status of trial NCT00840411?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2002-09. Estimated completion is 2002-10.

What conditions does trial NCT00840411 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT00840411?

The interventions under investigation include: Clarithromycin ER 500 mg tablets (DRUG), BIAXIN® XL 500 mg tablets (DRUG).

Who is sponsoring clinical trial NCT00840411?

This trial is sponsored by Teva Pharmaceuticals U, which has 19 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00840411 being conducted?

This trial has 1 study location across Missouri. 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 NCT00840411's enrollment target sits among peer trials

66 342nd of 1090 higher than 740 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 NCT00840411, the US trial registry maintained by the National Library of Medicine. NCT00840411 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.