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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00602719
The ClinicalTrials.gov registry entry for NCT00602719 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, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (82% lower). The listed sponsor is Roxane Laboratories, which has 93 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.