NCT00450853

Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Granisetron in Cancer Patients

Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Granisetron in Cancer Patients Treated With Platinum Based Chemotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Objective: to evaluate the bioavailability of subcutaneous granisetron.Patients 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 granisetron.Patients 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.

Conditions

• Vomiting

Interventions

Type	Name	Description
DRUG	granisetron	Granisetron SC followed by granisetron IV

Timeline

• Start date: 2005-04-01
• Primary completion: 2005-11-01
• Completion: 2005-11-01
• First posted: 2007-03-22
• Last updated: 2015-01-27

Locations

1 site across 1 country: Spain