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NCT00648193 · ClinicalTrials.gov registry record · Early Phase 1
Fasting Study of Paroxetine Hydrochloride Tablets 40 mg and Paxil® Tablets 40 mg
A Early Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 36
- Enrollment target
NCT00648193: Completed Early Phase 1 study, sponsored by Mylan Pharmaceuticals.
NCT00648193 is a Early Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 36 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00648193, a Early Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
The objective of this study is to investigate the bioequivalence of Mylan's paroxetine hydrochloride 40 mg tablets to GSK's Paxil® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose administered under fasting conditions to healthy adult volunteers.
Interventions
- DRUG Paroxetine hydrochloride 40 mg tablet
- DRUG Paxil® 40 mg Table
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2006-12 |
| Est. Completion | 2007-01 |
| Phase | Early Phase 1 |
What the finished NCT00648193 record still lists
NCT00648193 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 2 interventions - of which Paroxetine hydrochloride 40 mg tablet is the first listed.
NCT00648193 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00648193 about?
NCT00648193 is a clinical study titled "Fasting Study of Paroxetine Hydrochloride Tablets 40 mg and Paxil® Tablets 40 mg". The objective of this study is to investigate the bioequivalence of Mylan's paroxetine hydrochloride 40 mg tablets to GSK's Paxil® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose administered under fasting conditions to healthy adult volunteers.
What is the current status of trial NCT00648193?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 36 participants. The study started on 2006-12. Estimated completion is 2007-01.
What interventions are being tested in trial NCT00648193?
The interventions under investigation include: Paroxetine hydrochloride 40 mg tablet (DRUG), Paxil® 40 mg Table (DRUG).
Who is sponsoring clinical trial NCT00648193?
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 NCT00648193's enrollment target sits among peer trials
36 712th of 2000 higher than 1,267 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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