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NCT00649259 · ClinicalTrials.gov registry record · Phase 1

Food Study of Oxybutynin Chloride ER Tablets 10 mg and Ditropan XL® Tablets 10 mg

A Phase 1 study, sponsored by Mylan Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
39
Enrollment target

NCT00649259 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 39 participants.

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The verdict

NCT00649259, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
39 participants
Enrollment target

Study Summary

The objective of this study was to investigate the single-dose relative bioavailability of Mylan's oxybutynin chloride extended-release tablets to ALZA's Ditropan XL® tablets following an oral, single 20 mg (2 x 10 mg) dose under fed conditions.

Interventions

  • DRUG Oxybutynin Chloride ER Tablets 10 mg
  • DRUG Ditropan XL® Tablets 10 mg

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2002-10
Est. Completion 2002-11
Phase Phase 1

Sponsor

Mylan Pharmaceuticals

146 total trials

What the Registry Record Tells You About NCT00649259

The ClinicalTrials.gov registry entry for NCT00649259 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 39 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 ER Tablets 10 mg is the first listed.

NCT00649259 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00649259 about?

NCT00649259 is a clinical study titled "Food Study of Oxybutynin Chloride ER Tablets 10 mg and Ditropan XL® Tablets 10 mg". The objective of this study was to investigate the single-dose relative bioavailability of Mylan's oxybutynin chloride extended-release tablets to ALZA's Ditropan XL® tablets following an oral, single 20 mg (2 x 10 mg) dose under fed conditions.

What is the current status of trial NCT00649259?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2002-10. Estimated completion is 2002-11.

What interventions are being tested in trial NCT00649259?

The interventions under investigation include: Oxybutynin Chloride ER Tablets 10 mg (DRUG), Ditropan XL® Tablets 10 mg (DRUG).

Who is sponsoring clinical trial NCT00649259?

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.