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Sponsored by: |
Roxane Laboratories |
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Information provided by: | Roxane Laboratories |
ClinicalTrials.gov Identifier: | NCT00694187 |
The objective of this study was to show the bioequivalence of a Roxane Laboratories' Zaleplon Capsules, 10 mg, to Sonata ® Capsules, 10 mg (Jones Pharma) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design
Condition | Intervention |
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Short Term Treatment of Insomnia |
Drug: Zaleplon |
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 Zaleplon 10 mg Capsules Under Fasting Conditions. |
Enrollment: | 39 |
Study Start Date: | January 2004 |
Study Completion Date: | February 2004 |
Primary Completion Date: | February 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:
United States, Texas | |
Novum Pharmaceutical Research Services | |
Houston, Texas, United States, 77042 |
Principal Investigator: | So Ran Hong, M.D. | Novum Pharmaceutical Research Services |
Responsible Party: | Roxane Laboratories, Inc. ( Elizabeth Ernst, Director, DRA-MA ) |
Study ID Numbers: | ZALE-01 |
Study First Received: | June 6, 2008 |
Last Updated: | June 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00694187 |
Health Authority: | United States: Institutional Review Board |
Zaleplon |
Therapeutic Uses Physiological Effects of Drugs Hypnotics and Sedatives Central Nervous System Depressants |
Central Nervous System Agents Anticonvulsants Pharmacologic Actions |