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NCT00650325 · ClinicalTrials.gov registry record · Phase 1
Study of Sertraline Hydrochloride Tablets 100 mg and Zoloft® Tablets 100 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
NCT00650325 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 49 participants.
The verdict
NCT00650325, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
Study Summary
The objective of this study was to investigate the bioequivalence of Mylan's sertraline hydrochloride 100 mg tablets to Pfizer's Zoloft® 100 mg tablets following a single, oral 100 mg (1 x 100 mg) dose administered under fasting conditions.
Interventions
- DRUG Sertraline Hydrochloride Tablets 100 mg
- DRUG Zoloft® Tablets 100 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2002-11 |
| Est. Completion | 2002-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00650325
The ClinicalTrials.gov registry entry for NCT00650325 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 49 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 Sertraline Hydrochloride Tablets 100 mg is the first listed.
NCT00650325 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00650325 about?
NCT00650325 is a clinical study titled "Study of Sertraline Hydrochloride Tablets 100 mg and Zoloft® Tablets 100 mg". The objective of this study was to investigate the bioequivalence of Mylan's sertraline hydrochloride 100 mg tablets to Pfizer's Zoloft® 100 mg tablets following a single, oral 100 mg (1 x 100 mg) dose administered under fasting conditions.
What is the current status of trial NCT00650325?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2002-11. Estimated completion is 2002-12.
What interventions are being tested in trial NCT00650325?
The interventions under investigation include: Sertraline Hydrochloride Tablets 100 mg (DRUG), Zoloft® Tablets 100 mg (DRUG).
Who is sponsoring clinical trial NCT00650325?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
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