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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: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.
NCT00650325 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 49 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00650325 record still lists
NCT00650325 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 2 interventions - of which Sertraline Hydrochloride Tablets 100 mg is the first listed.
NCT00650325 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00650325's enrollment target sits among peer trials
49 1017th of 2000 higher than 976 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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