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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: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.
NCT00648843 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00648843 record still lists
NCT00648843 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Oxybutynin Chloride Extended-release Tablets 5 mg is the first listed.
NCT00648843 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00648843's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 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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