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NCT00648427 · ClinicalTrials.gov registry record · Phase 1
Fasting Study of Paroxetine Hydrochloride Controlled-Release Tablets 25 mg to Paxil CR™ Tablets 25 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
NCT00648427: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.
NCT00648427 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 75 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00648427, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
Study Summary
The objective of this study was to investigate the bioequivalence of Mylan's paroxetine hydrochloride controlled-release 25 mg tablets to GSK's Paxil CR™ 25 mg tablets following a single, oral 25 mg (1 x 25 mg) dose administered under fasting conditions.
Interventions
- DRUG Paroxetine Hydrochloride Controlled-Release Tablets 25 mg
- DRUG Paxil CR™ Tablets 25 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2005-04 |
| Est. Completion | 2005-05 |
| Phase | Phase 1 |
What the finished NCT00648427 record still lists
NCT00648427 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher).
The record links to 0 conditions, and to 2 interventions - of which Paroxetine Hydrochloride Controlled-Release Tablets 25 mg is the first listed.
NCT00648427 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00648427 about?
NCT00648427 is a clinical study titled "Fasting Study of Paroxetine Hydrochloride Controlled-Release Tablets 25 mg to Paxil CR™ Tablets 25 mg". The objective of this study was to investigate the bioequivalence of Mylan's paroxetine hydrochloride controlled-release 25 mg tablets to GSK's Paxil CR™ 25 mg tablets following a single, oral 25 mg (1 x 25 mg) dose administered under fasting conditions.
What is the current status of trial NCT00648427?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2005-04. Estimated completion is 2005-05.
What interventions are being tested in trial NCT00648427?
The interventions under investigation include: Paroxetine Hydrochloride Controlled-Release Tablets 25 mg (DRUG), Paxil CR™ Tablets 25 mg (DRUG).
Who is sponsoring clinical trial NCT00648427?
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 NCT00648427's enrollment target sits among peer trials
75 711th of 2000 higher than 1,276 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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