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NCT00649272 · ClinicalTrials.gov registry record · Phase 1

Fasting Study of Oxybutynin Chloride Extended-Release Tablets 15 mg and Ditropan XL® Tablets 15 mg

A Phase 1 study, sponsored by Mylan Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
80
Enrollment target

NCT00649272 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 80 participants.

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The verdict

NCT00649272, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
80 participants
Enrollment target

Study Summary

The objective of this study was to investigate the bioequivalence of Oxybutynin Chloride Extended-Release Tablets, 15 mg (Mylan Pharmaceuticals Inc.) to Ditropan XL® Extended- Release Tablets, 15 mg (ALZA Corporation; Distributed and marketed by: Ortho-McNeil Pharmaceuticals Inc.) following a single, oral 15 mg dose (1 x 15 mg tablet) under fasting conditions.

Interventions

  • DRUG Oxybutynin Chloride Extended-Release Tablets, 15 mg
  • DRUG Ditropan XL® Extended-release tablets, 15 mg

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2006-01
Est. Completion 2006-02
Phase Phase 1

Sponsor

Mylan Pharmaceuticals

146 total trials

What the Registry Record Tells You About NCT00649272

The ClinicalTrials.gov registry entry for NCT00649272 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Oxybutynin Chloride Extended-Release Tablets, 15 mg is the first listed.

NCT00649272 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00649272 about?

NCT00649272 is a clinical study titled "Fasting Study of Oxybutynin Chloride Extended-Release Tablets 15 mg and Ditropan XL® Tablets 15 mg". The objective of this study was to investigate the bioequivalence of Oxybutynin Chloride Extended-Release Tablets, 15 mg (Mylan Pharmaceuticals Inc.) to Ditropan XL® Extended- Release Tablets, 15 mg (ALZA Corporation; Distributed and marketed by: Ortho-McNeil Pharmaceuticals Inc.) following a single...

What is the current status of trial NCT00649272?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2006-01. Estimated completion is 2006-02.

What interventions are being tested in trial NCT00649272?

The interventions under investigation include: Oxybutynin Chloride Extended-Release Tablets, 15 mg (DRUG), Ditropan XL® Extended-release tablets, 15 mg (DRUG).

Who is sponsoring clinical trial NCT00649272?

This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.

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.