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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 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 75 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00648427
The ClinicalTrials.gov registry entry for NCT00648427 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Paroxetine Hydrochloride Controlled-Release Tablets 25 mg is the first listed.
NCT00648427 reports 0 study locations.
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.
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