Trials / Completed
CompletedNCT00601666
Bioequivalency Study of Zolpidem Tartrate Under Fasting Conditions
A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of Zolpidem Tartrate Tablets 10 MG Under Fasting Conditions
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Roxane Laboratories · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Zolpidem |
Timeline
- Start date
- 2004-03-01
- Primary completion
- 2004-03-01
- Completion
- 2004-03-01
- First posted
- 2008-01-28
- Last updated
- 2018-01-23
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00601666. Inclusion in this directory is not an endorsement.