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NCT00939692 · ClinicalTrials.gov registry record · Phase 1

Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Topiramate Tablets Under Fasted Conditions

A Phase 1 study, sponsored by Torrent Pharmaceuticals Limited.

Completed
Registry status
Phase 1
Development phase
26
Enrollment target

NCT00939692: Completed Phase 1 study, sponsored by Torrent Pharmaceuticals Limited.

NCT00939692 is a Phase 1 study that has completed, run by Torrent Pharmaceuticals Limited. The registered enrollment target is 26 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00939692, a Phase 1 study, has completed, sponsored by Torrent Pharmaceuticals Limited.

COMPLETED
Registry status
Phase 1
Development phase
26 participants
Enrollment target

Study Summary

* Objective: * Compare the bioequivalence of a test topiramate formulation (Torrent Pharmaceuticals Limited) to an equivalent oral dose of the commercially available topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.) in a test population of 26 adult subjects under fasted conditions. * Clinical Design: * Studies were Randomized, Two-Way Crossover, Single-Dose,Open-Label in healthy human adult subjects.

Interventions

  • DRUG Topiramate

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2007-01
Est. Completion 2007-04
Phase Phase 1

Sponsor

Torrent Pharmaceuticals Limited

7 total trials

What the Registry Record Tells You About NCT00939692

The ClinicalTrials.gov registry entry for NCT00939692 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Torrent Pharmaceuticals Limited, which has 7 total studies on file at ClinicalTrials.gov.

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

NCT00939692 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00939692 about?

NCT00939692 is a clinical study titled "Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Topiramate Tablets Under Fasted Conditions". * Objective: * Compare the bioequivalence of a test topiramate formulation (Torrent Pharmaceuticals Limited) to an equivalent oral dose of the commercially available topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.) in a test population of 26 adult subjects under fasted conditions. * Clinical...

What is the current status of trial NCT00939692?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2007-01. Estimated completion is 2007-04.

What interventions are being tested in trial NCT00939692?

The interventions under investigation include: Topiramate (DRUG).

Who is sponsoring clinical trial NCT00939692?

This trial is sponsored by Torrent Pharmaceuticals Limited, which has 7 total clinical trials registered on ClinicalTrials.gov.

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

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, the data changelog, or report a data error.