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NCT00648843 · ClinicalTrials.gov registry record · Phase 1
Food Study of Oxybutynin Chloride Extended-release Tablets 5 mg and Ditropan XL® Tablets 5 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT00648843 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 28 participants.
The verdict
NCT00648843, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 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 (4 x 5 mg) dose under fed conditions.
Interventions
- DRUG Oxybutynin Chloride Extended-release Tablets 5 mg
- DRUG Ditropan XL® Tablets 5 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2002-12 |
| Est. Completion | 2003-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00648843
The ClinicalTrials.gov registry entry for NCT00648843 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 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 5 mg is the first listed.
NCT00648843 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00648843 about?
NCT00648843 is a clinical study titled "Food 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 an oral, single 20 mg (4 x 5 mg) dose under fed conditions.
What is the current status of trial NCT00648843?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2002-12. Estimated completion is 2003-01.
What interventions are being tested in trial NCT00648843?
The interventions under investigation include: Oxybutynin Chloride Extended-release Tablets 5 mg (DRUG), Ditropan XL® Tablets 5 mg (DRUG).
Who is sponsoring clinical trial NCT00648843?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
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