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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00511823 |
Purpose
This A Three-Part Drug-Drug Interaction Study To Evaluate Effects of Casopitant On Dolasetron, Granisetron or Rosiglitazone When Co-Administered in Healthy Adults
| Condition | Intervention | Phase |
|---|---|---|
|
Postoperative Nausea and Vomiting Chemotherapy-Induced Nausea and Vomiting |
Drug: casopitant |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Three-Part, Two Period, Single Sequence Study to Assess the Pharmacokinetic Interaction Between Repeat Doses of Oral Casopitant and Repeat Oral Doses of Dolasetron, Granisetron or Rosiglitazone When Co-Administered in Healthy Adult Subjects |
| Enrollment: | 16 |
| Study Start Date: | July 2007 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Study Director, GSK |
| ClinicalTrials.gov Identifier: | NCT00511823 History of Changes |
| Other Study ID Numbers: | NKV110483 |
| Study First Received: | August 2, 2007 |
| Last Updated: | May 15, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
casopitant, dolasetron, granisetron, rosiglitazone, CYP2D6, |
CYP2C8, CYP3A4, drug-drug interaction, pharmacokinetics, safety |
|
Nausea Vomiting Postoperative Nausea and Vomiting Signs and Symptoms, Digestive Signs and Symptoms Postoperative Complications Pathologic Processes Granisetron Dolasetron mesylate Rosiglitazone Antiemetics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hypoglycemic Agents |