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NCT00649727 · ClinicalTrials.gov registry record · Phase 1

Fed Study of Oxybutynin Chloride Extended-release Tablets 10 mg and Ditropan XL® Tablets 10 mg

A Phase 1 study of Healthy, sponsored by Mylan Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target
1
Study location

NCT00649727 is a Phase 1 study of Healthy that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 24 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00649727, a Phase 1 study of Healthy, has completed, sponsored by Mylan Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target
1
Study location

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.

Conditions Studied

Interventions

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

Study Locations (1)

West Virginia

  • Kendle International Inc. - Morgantown

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2002-07
Est. Completion 2002-08
Phase Phase 1

Sponsor

Mylan Pharmaceuticals

146 total trials

What the Registry Record Tells You About NCT00649727

The ClinicalTrials.gov registry entry for NCT00649727 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Oxybutynin Chloride ER Tablets 10 mg is the first listed.

NCT00649727 reports 1 study location spanning 1 distinct geographic area - top geographies include West Virginia.

Frequently Asked Questions

What is clinical trial NCT00649727 about?

NCT00649727 is a clinical study titled "Fed Study of Oxybutynin Chloride Extended-release 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 NCT00649727?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2002-07. Estimated completion is 2002-08.

What conditions does trial NCT00649727 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT00649727?

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

Who is sponsoring clinical trial NCT00649727?

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

Where is trial NCT00649727 being conducted?

This trial has 1 study location across West Virginia. 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.