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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 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.

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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.

Conditions Studied

Healthy

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

Sponsor

Teva Pharmaceuticals U

19 total trials

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What the Registry Record Tells You About NCT00840411

The ClinicalTrials.gov registry entry for NCT00840411 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (90% lower). The listed sponsor is Teva Pharmaceuticals U, which has 19 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.