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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 is a Phase 1 study that has completed, run by Actavis. The registered enrollment target is 30 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00864344
The ClinicalTrials.gov registry entry for NCT00864344 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actavis, which has 79 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sertraline HCl 100 mg tablets, single dose is the first listed.
NCT00864344 reports 0 study locations.
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.
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