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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: Completed Phase 1 study of Healthy, sponsored by Actavis.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00864019 record still lists
NCT00864019 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 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00864019's enrollment target sits among peer trials
30 678th of 1090 higher than 363 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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