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NCT00650481 · ClinicalTrials.gov registry record · Phase 1

Fasting Study of Oxybutynin Chloride Extended-release Tablets 5 mg and Ditropan XL® Tablets 5 mg

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

Completed
Registry status
Phase 1
Development phase
60
Enrollment target
1
Study location

NCT00650481 is a Phase 1 study of Healthy that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 60 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00650481, a Phase 1 study of Healthy, has completed, sponsored by Mylan Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
60 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 a single, oral 20 mg (4 x 5 mg) dose under fasting conditions.

Conditions Studied

Healthy

Interventions

  • DRUG Oxybutynin Chloride Extended-release Tablets 5 mg
  • DRUG Ditropan XL® Tablets 5 mg

Study Locations (1)

North Dakota

  • PRACS Institute, Ltd. - Fargo

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2002-12
Est. Completion 2003-01
Phase Phase 1

Sponsor

Mylan Pharmaceuticals

146 total trials

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What the Registry Record Tells You About NCT00650481

The ClinicalTrials.gov registry entry for NCT00650481 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 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 (91% 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 Extended-release Tablets 5 mg is the first listed.

NCT00650481 reports 1 study location spanning 1 distinct geographic area - top geographies include North Dakota.

Frequently Asked Questions

What is clinical trial NCT00650481 about?

NCT00650481 is a clinical study titled "Fasting Study of Oxybutynin Chloride Extended-release Tablets 5 mg and Ditropan XL® Tablets 5 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 a single, oral 20 mg (4 x 5 mg) dose under fasting conditions.

What is the current status of trial NCT00650481?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2002-12. Estimated completion is 2003-01.

What conditions does trial NCT00650481 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT00650481?

The interventions under investigation include: Oxybutynin Chloride Extended-release Tablets 5 mg (DRUG), Ditropan XL® Tablets 5 mg (DRUG).

Who is sponsoring clinical trial NCT00650481?

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

Where is trial NCT00650481 being conducted?

This trial has 1 study location across North Dakota. 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.