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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00650403
The ClinicalTrials.gov registry entry for NCT00650403 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (90% lower). The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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