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Sponsored by: |
Roxane Laboratories |
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Information provided by: | Roxane Laboratories |
ClinicalTrials.gov Identifier: | NCT00618111 |
The objective of this study was to assess bioequivalence of a potential generic 1 mg granisetron tablet formulation compared with Roche Laboratories' 1 mg granisetron tablet, Kytril, following a single 1 mg dose, under fed conditions.
Condition | Intervention |
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Nausea Vomiting |
Drug: Granisetron |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Bio-equivalence Study |
Official Title: | A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Granisetron Hydrochloride 1 mg Tablets Under Fed Conditions |
Ages Eligible for Study: | 19 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: | GRAN-T1-PVFD-1 |
Study First Received: | January 30, 2008 |
Last Updated: | February 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00618111 |
Health Authority: | United States: Institutional Review Board |
Prevention of nausea and vomiting associated with radiation or chemotherapy |
Signs and Symptoms Vomiting Malnutrition Signs and Symptoms, Digestive |
Nausea Granisetron Serotonin |
Neurotransmitter Agents Serotonin Antagonists Serotonin Agents Molecular Mechanisms of Pharmacological Action Autonomic Agents Therapeutic Uses |
Physiological Effects of Drugs Gastrointestinal Agents Antiemetics Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions |