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PHARMACOKINETICS

Pharmacokinetic Evaluation and Safety Profile of a 15-Minute Versus 30-Second Infusion of Palonosetron in Healthy Subjects

Ajit Shah, PhD, Timothy DeGroot and Glen Apseloff, MD

From MGI PHARMA, Bloomington, Minnesota (Dr Shah, Mr DeGroot) and The Ohio State University, Columbus (Dr Apseloff). Dr Apseloff is a Fellow of the American College of Clinical Pharmacology. Financial disclosures: Dr Apseloff has received research support from MGI PHARMA. Dr Shah and Mr DeGroot are employees of MGI PHARMA. This study was approved by the Western Institutional Review Board.

Palonosetron is a potent, selective 5-HT3 receptor antagonist effective in the prevention of acute and delayed chemotherapy-induced nausea and vomiting. In practice, 5-HT3 receptor antagonists, including palonosetron, are often coadministered with dexamethasone over approximately 15 minutes, although the approval of palonosetron was based on administration as a 30-second infusion. This open-label, randomized, 2-way crossover trial compared the pharmacokinetics and safety of palonosetron 0.25 mg administered as a 15-minute 50-mL intravenous infusion with a 30-second 5-mL infusion. Aside from an anticipated 40% decrease in maximum plasma concentration after a 15-minute infusion, the pharmacokinetics of palonosetron (including area under the plasma concentration-time curve [AUC], plasma elimination half-life, total body clearance, and apparent volume of distribution at steady state) were similar for both treatments. Both treatments were well tolerated, with no significant changes in vital signs or electrocardiograms. Palonosetron infused over 15 minutes is well tolerated, with an AUC0-{infty} equivalent to a 30-second infusion.

Key Words: Pharmacokinetics • chemotherapy-induced nausea and vomiting • antiemetic • 5-HT3 receptor antagonist • palonosetron

Address for reprints: Ajit Shah, PhD, MGI PHARMA, 5775 West Old Shakopee Road, Suite 100, Bloomington, MN 55437-3174; e-mail: ajit.shah{at}mgipharma.com.






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