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Sponsored by: |
Roxane Laboratories |
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Information provided by: | Roxane Laboratories |
ClinicalTrials.gov Identifier: | NCT00602719 |
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.
Condition | Intervention |
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Insomnia |
Drug: Zolpidem |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of Zolpidem Tartrate Tablets 10 MG Under Fed Conditions |
Enrollment: | 30 |
Study Start Date: | March 2004 |
Study Completion Date: | March 2004 |
Primary Completion Date: | March 2004 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Roxane Laboratories, Inc. ( Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs ) |
Study ID Numbers: | ZOLP-02 |
Study First Received: | January 15, 2008 |
Last Updated: | February 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00602719 |
Health Authority: | United States: Food and Drug Administration |
Zolpidem Malnutrition |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses GABA Agonists Hypnotics and Sedatives |
Physiological Effects of Drugs Central Nervous System Depressants GABA Agents Central Nervous System Agents Pharmacologic Actions |