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Sponsored by: |
Teva Pharmaceuticals USA |
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Information provided by: | Teva Pharmaceuticals USA |
ClinicalTrials.gov Identifier: | NCT00829998 |
The objective of this study was to compare the relative bioavailability of Zaleplon 10 mg Capsules manufactured by TEVA Pharmaceuticals USA and Sonata® 10 mg Capsules manufactured by Wyeth Laboratories in healthy, non-smoking adults under fasting conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Zaleplon 10 mg Capsules Drug: Sonata® 10 mg Capsules |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Relative Bioavailability Study of Zaleplon 10mg Capsules Under Fasting Conditions |
Enrollment: | 40 |
Study Start Date: | February 2004 |
Study Completion Date: | February 2004 |
Primary Completion Date: | February 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Zaleplon: Experimental
Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period
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Drug: Zaleplon 10 mg Capsules
1 x 10 mg, single-dose fasting
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Sonata®: Active Comparator
Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period
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Drug: Sonata® 10 mg Capsules
1 x 10 mg, single-dose fasting
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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, Texas | |
Novum Pharmaceutical Research Services | |
Houston, Texas, United States, 77040 |
Principal Investigator: | So Ran Hong, M.D. | Novum Pharmaceutical Research Services |
Study ID Numbers: | BO46501 |
Study First Received: | January 26, 2009 |
Results First Received: | July 6, 2009 |
Last Updated: | July 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00829998 History of Changes |
Health Authority: | United States: Institutional Review Board |
Bioequivalence Healthy Subjects |
Zaleplon Hypnotics and Sedatives Central Nervous System Depressants Healthy Anticonvulsants |
Zaleplon Therapeutic Uses Physiological Effects of Drugs Hypnotics and Sedatives |
Central Nervous System Depressants Central Nervous System Agents Anticonvulsants Pharmacologic Actions |