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NCT00601315 · ClinicalTrials.gov registry record · NA

Bioequivalency Study of Clarithromycin Tablets Under Fasting Conditions

A NA study of Infection, sponsored by Roxane Laboratories.

Completed
Registry status
NA
Development phase
40
Enrollment target
1
Study location

NCT00601315 is a NA study of Infection that has completed, run by Roxane Laboratories. The registered enrollment target is 40 participants, below the 725-participant average among 41 other Infection trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00601315, a NA study of Infection, has completed, sponsored by Roxane Laboratories.

COMPLETED
Registry status
NA
Development phase
40 participants
Enrollment target
1
Study location

Study Summary

The objective of this study was the bioequivalence of a potential generic 250 mg clarithromycin tablet formulation compared with Abbott Laboratories 250 mg clarithromycin tablet, Biaxin® following a single 250 mg dose, administered in the fasted state.

Conditions Studied

Interventions

  • DRUG Clarithromycin

Study Locations (1)

Arizona

  • MDS Pharma Services - Phoenix

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2003-04
Est. Completion 2003-05
Phase NA

Sponsor

Roxane Laboratories

93 total trials

What the Registry Record Tells You About NCT00601315

The ClinicalTrials.gov registry entry for NCT00601315 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 725-participant average among 41 other Infection trials with a reported enrollment target (94% lower). The listed sponsor is Roxane Laboratories, which has 93 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Infection appearing as the primary indexed condition, and to 1 intervention - of which Clarithromycin is the first listed.

NCT00601315 reports 1 study location spanning 1 distinct geographic area - top geographies include Arizona.

Frequently Asked Questions

What is clinical trial NCT00601315 about?

NCT00601315 is a clinical study titled "Bioequivalency Study of Clarithromycin Tablets Under Fasting Conditions". The objective of this study was the bioequivalence of a potential generic 250 mg clarithromycin tablet formulation compared with Abbott Laboratories 250 mg clarithromycin tablet, Biaxin® following a single 250 mg dose, administered in the fasted state.

What is the current status of trial NCT00601315?

This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2003-04. Estimated completion is 2003-05.

What conditions does trial NCT00601315 study?

This clinical trial studies the following conditions: Infection.

What interventions are being tested in trial NCT00601315?

The interventions under investigation include: Clarithromycin (DRUG).

Who is sponsoring clinical trial NCT00601315?

This trial is sponsored by Roxane Laboratories, which has 93 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00601315 being conducted?

This trial has 1 study location across Arizona. 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.