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Sponsored by: |
Teva Pharmaceuticals USA |
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Information provided by: | Teva Pharmaceuticals USA |
ClinicalTrials.gov Identifier: | NCT00833521 |
The objective of this study is to compare the relative bioavailability of Zolpidem tartrate 10 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of AMBIEN® tablets(G.D. Searle & Co.) in healthy, adult, non-smoking subjects under fasting conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Zolpidem 10 mg tablets Drug: AMBIEN® 10 mg tablets |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Relative BioAvailability Study of Zolpidem Tartrate 10 mg Tablets Under Fasting Conditions |
Enrollment: | 38 |
Study Start Date: | February 2002 |
Study Completion Date: | February 2002 |
Primary Completion Date: | February 2002 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Zolpidem: Experimental
Zolpidem Tartrate 10 mg Tablet (test) dosed in first period followed by Ambien® 10 mg Tablet (reference) dosed in second period
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Drug: Zolpidem 10 mg tablets
1 x 10 mg
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Ambien®: Active Comparator
Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in second period
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Drug: AMBIEN® 10 mg tablets
1 x 10 mg
|
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Novum Pharmaceutical Research Services | |
Pittsburgh, Pennsylvania, United States, 15206 |
Principal Investigator: | Shirley Ann Kennedy, M.D. | Novum Pharmaceutical Research Services |
Study ID Numbers: | B016539 |
Study First Received: | January 30, 2009 |
Results First Received: | July 6, 2009 |
Last Updated: | July 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00833521 History of Changes |
Health Authority: | United States: Institutional Review Board |
Bioequivalence Healthy Subjects |
Zolpidem Neurotransmitter Agents GABA Agonists |
Hypnotics and Sedatives Central Nervous System Depressants Healthy |
Zolpidem 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 |