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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: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.
NCT00649272 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 80 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.
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
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2006-01 |
| Est. Completion | 2006-02 |
| Phase | Phase 1 |
What the finished NCT00649272 record still lists
NCT00649272 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher).
The record links to 0 conditions, and to 2 interventions - of which Oxybutynin Chloride Extended-Release Tablets, 15 mg is the first listed.
NCT00649272 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00649272's enrollment target sits among peer trials
80 672nd of 2000 higher than 1,305 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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