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NCT00864019 · ClinicalTrials.gov registry record · Phase 1
A Relative Bioavailability Study of Sertraline HCl 100 mg Tablets Under Non-fasting Conditions
A Phase 1 study of Healthy, sponsored by Actavis.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT00864019 is a Phase 1 study of Healthy that has completed, run by Actavis. The registered enrollment target is 30 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00864019, a Phase 1 study of Healthy, has completed, sponsored by Actavis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
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. Following an overnight fast of at least 10 hours, subjects will consume a standard high-calorie, high-fat breakfast meal. This standard breakfast will begin 30 minutes prior to each dose.
Conditions Studied
Interventions
- DRUG Sertraline HCl 100 mg tablets, single dose
- DRUG Zoloft® 100 mg tablets, single dose
Study Locations (1)
Texas
- CEDRA Clinical Research, LLC - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2004-08 |
| Est. Completion | 2004-08 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00864019
The ClinicalTrials.gov registry entry for NCT00864019 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, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower). The listed sponsor is Actavis, which has 79 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Sertraline HCl 100 mg tablets, single dose is the first listed.
NCT00864019 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT00864019 about?
NCT00864019 is a clinical study titled "A Relative Bioavailability Study of Sertraline HCl 100 mg Tablets Under Non-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. Following an overnight fast of ...
What is the current status of trial NCT00864019?
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 conditions does trial NCT00864019 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT00864019?
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 NCT00864019?
This trial is sponsored by Actavis, which has 79 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00864019 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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