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NCT00864344 · ClinicalTrials.gov registry record · Phase 1
A Relative Bioavailability Study of Sertraline HCl 100 mg Tablets Under Fasting Conditions
A Phase 1 study, sponsored by Actavis.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT00864344: Completed Phase 1 study, sponsored by Actavis.
NCT00864344 is a Phase 1 study that has completed, run by Actavis. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00864344, a Phase 1 study, has completed, sponsored by Actavis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
To compare the rate of absorption and oral bioavailability of a test formulation of Sertraline 100 mg tablets manufactured by Purepac Pharmaceutical Company to an equivalent oral dose of the commercially available reference product, Zoloft® manufactured by Pfizer Inc. administrated to healthy subjects after a 10-ghour overnight fast
Interventions
- DRUG Sertraline HCl 100 mg tablets, single dose
- DRUG Zoloft® 100 mg tablets, single dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2004-08 |
| Est. Completion | 2004-08 |
| Phase | Phase 1 |
What the finished NCT00864344 record still lists
NCT00864344 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Sertraline HCl 100 mg tablets, single dose is the first listed.
NCT00864344 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00864344 about?
NCT00864344 is a clinical study titled "A Relative Bioavailability Study of Sertraline HCl 100 mg Tablets Under Fasting Conditions". To compare the rate of absorption and oral bioavailability of a test formulation of Sertraline 100 mg tablets manufactured by Purepac Pharmaceutical Company to an equivalent oral dose of the commercially available reference product, Zoloft® manufactured by Pfizer Inc. administrated to healthy subjec...
What is the current status of trial NCT00864344?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2004-08. Estimated completion is 2004-08.
What interventions are being tested in trial NCT00864344?
The interventions under investigation include: Sertraline HCl 100 mg tablets, single dose (DRUG), Zoloft® 100 mg tablets, single dose (DRUG).
Who is sponsoring clinical trial NCT00864344?
This trial is sponsored by Actavis, which has 79 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00864344's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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