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NCT00601666 · ClinicalTrials.gov registry record · NA
Bioequivalency Study of Zolpidem Tartrate Under Fasting Conditions
A NA study, sponsored by Roxane Laboratories.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT00601666 is a NA study that has completed, run by Roxane Laboratories. The registered enrollment target is 30 participants.
The verdict
NCT00601666, a NA study, has completed, sponsored by Roxane Laboratories.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
The objective of this study was the bioequivalence of a Roxane Laboratories' Zolpidem Tablets, 10 mg, to Ambien® Tablets, 10 mg (Sanofi-Synthelabo Inc.) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.
Interventions
- DRUG Zolpidem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2004-03 |
| Est. Completion | 2004-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00601666
The ClinicalTrials.gov registry entry for NCT00601666 describes a study currently listed as completed, categorized as NA. 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 Roxane Laboratories, which has 93 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Zolpidem is the first listed.
NCT00601666 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00601666 about?
NCT00601666 is a clinical study titled "Bioequivalency Study of Zolpidem Tartrate Under Fasting Conditions". The objective of this study was the bioequivalence of a Roxane Laboratories' Zolpidem Tablets, 10 mg, to Ambien® Tablets, 10 mg (Sanofi-Synthelabo Inc.) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.
What is the current status of trial NCT00601666?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2004-03. Estimated completion is 2004-03.
What interventions are being tested in trial NCT00601666?
The interventions under investigation include: Zolpidem (DRUG).
Who is sponsoring clinical trial NCT00601666?
This trial is sponsored by Roxane Laboratories, which has 93 total clinical trials registered on ClinicalTrials.gov.
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