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Sponsored by: |
Roxane Laboratories |
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Information provided by: | Roxane Laboratories |
ClinicalTrials.gov Identifier: | NCT00602303 |
The objective of this study was the bioequivalence of a Roxane Laboratories' Torsemide Tablets, 20 mg, to Demadex® Tablets, 20 mg (Roche) under fasting conditions using a single-dose, 2-treatment, 2-period, crossover design.
Condition | Intervention |
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Edema |
Drug: Torsemide |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalency Study of 20 mg Torsemide Tablets Under Fasting Conditions |
Enrollment: | 28 |
Study Start Date: | September 2003 |
Study Completion Date: | September 2003 |
Primary Completion Date: | September 2003 (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, Missouri | |
Bio-Kinetic Clinical Applications, Inc. | |
Springfield, Missouri, United States, 65801 |
Principal Investigator: | Dennis Morrison, DO | Bio-Kinetic Clinical Applications, Inc. |
Responsible Party: | Roxane Laboratories, Inc. ( Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs ) |
Study ID Numbers: | TORE-01 |
Study First Received: | January 15, 2008 |
Last Updated: | February 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00602303 |
Health Authority: | United States: Food and Drug Administration |
Torsemide Edema |
Natriuretic Agents Therapeutic Uses Physiological Effects of Drugs Diuretics |
Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |