Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450853
Status:
COMPLETED
Last Update Posted:
2015-01-27
First Post:
2007-03-21
Brief Title:
Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Granisetron in Cancer Patients
Sponsor:
Clinica Universidad de Navarra Universidad de Navarra
Organization:
Clinica Universidad de Navarra Universidad de Navarra
Study Overview
Official Title:
Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Granisetron in Cancer Patients Treated With Platinum Based Chemotherapy
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective to evaluate the bioavailability of subcutaneous granisetronPatients receiving platinum-based chemotherapy will be randomized to receive granisetron 3 mg either subcutaneously or intravenously in a crossover manner during two cycles Blood and urine samples will be collected after each cycle
Detailed Description:
5-HT3 antagonists are one of the mainstays of antiemetic treatment and they are administered either intravenously or orally Nevertheless sometimes neither administration route is feasible such as in patients unable to admit oral intake managed in an outpatient setting Our objective is to evaluate the bioavailability of subcutaneous granisetronPatients receiving platinum-based chemotherapy will be randomized to receive granisetron 3 mg either subcutaneously or intravenously in a crossover manner during two cycles Blood and urine samples will be collected after each cycle Pharmacokinetics of SC and IV granisetron will be prospectively compared
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None