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NCT00829868 · ClinicalTrials.gov registry record · Phase 1
Zaleplon 10 mg Capsules Under Non-Fasting Conditions
A Phase 1 study, sponsored by Teva Pharmaceuticals USA.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT00829868: Completed Phase 1 study, sponsored by Teva Pharmaceuticals USA.
NCT00829868 is a Phase 1 study that has completed, run by Teva Pharmaceuticals USA. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00829868, a Phase 1 study, has completed, sponsored by Teva Pharmaceuticals USA.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
The objective of this study is to compare the relative bioavailability of zaleplon 10 mg capsules(manufactured and distributed by TEVA Pharmaceuticals USA) with that of SONATA® 10mg capsules (Wyeth-Ayerst Pharmaceuticals) in healthy, non-smoking, adult subjects under non-fasting conditions.
Primary Outcome
Bioequivalence based on Cmax
Interventions
- DRUG Zaleplon 10 mg Capsules
- DRUG SONATA® 10 mg capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2004-02 |
| Est. Completion | 2004-03 |
| Phase | Phase 1 |
What the finished NCT00829868 record still lists
NCT00829868 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 2 interventions - of which Zaleplon 10 mg Capsules is the first listed.
NCT00829868 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00829868 about?
NCT00829868 is a clinical study titled "Zaleplon 10 mg Capsules Under Non-Fasting Conditions". The objective of this study is to compare the relative bioavailability of zaleplon 10 mg capsules(manufactured and distributed by TEVA Pharmaceuticals USA) with that of SONATA® 10mg capsules (Wyeth-Ayerst Pharmaceuticals) in healthy, non-smoking, adult subjects under non-fasting conditions.
What is the current status of trial NCT00829868?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2004-02. Estimated completion is 2004-03.
What interventions are being tested in trial NCT00829868?
The interventions under investigation include: Zaleplon 10 mg Capsules (DRUG), SONATA® 10 mg capsules (DRUG).
Who is sponsoring clinical trial NCT00829868?
This trial is sponsored by Teva Pharmaceuticals USA, which has 83 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00829868's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 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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