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NCT00602719 · ClinicalTrials.gov registry record · NA
Bioequivalency Study of Zolpidem Tartrate Under Fed Conditions
A NA study of Insomnia, sponsored by Roxane Laboratories.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT00602719: Completed NA study of Insomnia, sponsored by Roxane Laboratories.
NCT00602719 is a NA study of Insomnia that has completed, run by Roxane Laboratories. The registered enrollment target is 30 participants, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00602719, a NA study of Insomnia, has completed, sponsored by Roxane Laboratories.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
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 fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.
Conditions Studied
Interventions
- DRUG Zolpidem
Study Locations (1)
North Dakota
- PRACS Institute, Ltd. - Fargo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2004-03 |
| Est. Completion | 2004-03 |
| Phase | NA |
What the finished NCT00602719 record still lists
NCT00602719 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 170-participant average among 151 other Insomnia trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Insomnia appearing as the primary indexed condition, and to 1 intervention - of which Zolpidem is the first listed.
NCT00602719 reports a single indexed study location in North Dakota.
Frequently Asked Questions
What is clinical trial NCT00602719 about?
NCT00602719 is a clinical study titled "Bioequivalency Study of Zolpidem Tartrate Under Fed 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 fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.
What is the current status of trial NCT00602719?
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 conditions does trial NCT00602719 study?
This clinical trial studies the following conditions: Insomnia.
What interventions are being tested in trial NCT00602719?
The interventions under investigation include: Zolpidem (DRUG).
Who is sponsoring clinical trial NCT00602719?
This trial is sponsored by Roxane Laboratories, which has 93 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00602719 being conducted?
This trial has 1 study location across North Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00602719's enrollment target sits among peer trials
30 122nd of 151 higher than 25 of 151 other Insomnia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Insomnia 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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