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NCT01591889 · ClinicalTrials.gov registry record · Phase 1

Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions

A Phase 1 study, sponsored by Roxane Laboratories.

Completed
Registry status
Phase 1
Development phase
28
Enrollment target

NCT01591889: Completed Phase 1 study, sponsored by Roxane Laboratories.

NCT01591889 is a Phase 1 study that has completed, run by Roxane Laboratories. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01591889, a Phase 1 study, has completed, sponsored by Roxane Laboratories.

COMPLETED
Registry status
Phase 1
Development phase
28 participants
Enrollment target

Study Summary

The objective of this study was to prove the bioequivalence of Roxane Laboratories' Tinidazole 500 mg Tablet under fed conditions.

Interventions

  • DRUG Tinidazole

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2009-09
Est. Completion 2009-09
Phase Phase 1
Roxane Laboratories

93 total trials

What the finished NCT01591889 record still lists

NCT01591889 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).

The record links to 0 conditions, and to 1 intervention - of which Tinidazole is the first listed.

NCT01591889 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01591889 about?

NCT01591889 is a clinical study titled "Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions". The objective of this study was to prove the bioequivalence of Roxane Laboratories' Tinidazole 500 mg Tablet under fed conditions.

What is the current status of trial NCT01591889?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2009-09. Estimated completion is 2009-09.

What interventions are being tested in trial NCT01591889?

The interventions under investigation include: Tinidazole (DRUG).

Who is sponsoring clinical trial NCT01591889?

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

How this trial's enrollment target compares

Where NCT01591889's enrollment target sits among peer trials

28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT01591889, the US trial registry maintained by the National Library of Medicine. NCT01591889 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.