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NCT00650403 · ClinicalTrials.gov registry record · Phase 1
Food Study of Paroxetine Hydrochloride Tablets 40 mg and Paxil® Tablets 40 mg
A Phase 1 study of Healthy, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
- 1
- Study location
NCT00650403: Completed Phase 1 study of Healthy, sponsored by Mylan Pharmaceuticals.
NCT00650403 is a Phase 1 study of Healthy that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 66 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00650403, a Phase 1 study of Healthy, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 66 participants
- Enrollment target
- 1
- Study location
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 fed conditions to healthy adult volunteers.
Conditions Studied
Interventions
- DRUG Paroxetine hydrochloride 40 mg tablet
- DRUG Paxil® 40 mg Tablet
Study Locations (1)
Missouri
- Gateway Medical Research, Inc. - Saint Charles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2006-12 |
| Est. Completion | 2007-01 |
| Phase | Phase 1 |
What the finished NCT00650403 record still lists
NCT00650403 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Paroxetine hydrochloride 40 mg tablet is the first listed.
NCT00650403 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT00650403 about?
NCT00650403 is a clinical study titled "Food 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 fed conditions to healthy adult volunteers.
What is the current status of trial NCT00650403?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2006-12. Estimated completion is 2007-01.
What conditions does trial NCT00650403 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT00650403?
The interventions under investigation include: Paroxetine hydrochloride 40 mg tablet (DRUG), Paxil® 40 mg Tablet (DRUG).
Who is sponsoring clinical trial NCT00650403?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00650403 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00650403's enrollment target sits among peer trials
66 342nd of 1090 higher than 740 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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