Pharmacokinetic evaluation and safety profile of a 15-minute versus 30-second infusion of palonosetron in healthy subjects

Journal of Clinical Pharmacology

Volumn 46, Issue 10, 2006, Pages 1139-1145

  Shah, Ajit ^a   DeGroot, Timothy ^a   Apseloff, Glen ^b  

^a GUILFORD PHARMACEUTICALS INC   (United States)

^b OHIO STATE UNIVERSITY   (United States)

Author keywords

5 HT3 receptor antagonist; Antiemetic; Chemotherapy induced nausea and vomiting; Palonosetron; Pharmacokinetics

Indexed keywords

PALONOSETRON;

ADULT; ANEMIA; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG HALF LIFE; DRUG SAFETY; DYSPEPSIA; ELECTROCARDIOGRAM; EXTRAVASATION; FEMALE; HEADACHE; HUMAN; HUMAN EXPERIMENT; INFUSION; INJECTION SITE PAIN; MALE; NORMAL HUMAN; RANDOMIZED CONTROLLED TRIAL; STEADY STATE; SYNCOPE; THROMBOPHLEBITIS; VEIN PUNCTURE; VITAL SIGN;

ADOLESCENT; ADULT; AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; CROSS-OVER STUDIES; FEMALE; HALF-LIFE; HEADACHE; HUMANS; INFUSIONS, INTRAVENOUS; ISOQUINOLINES; MALE; METABOLIC CLEARANCE RATE; MIDDLE AGED; QUINUCLIDINES; RECEPTORS, SEROTONIN, 5-HT3; SEROTONIN 5-HT3 RECEPTOR ANTAGONISTS; SEROTONIN ANTAGONISTS; TIME FACTORS;

EID: 33748666608     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270006291625     Document Type: Article

References (17)

1. 3 antagonists. Br J Cancer. 1997;76:1055-1061.
2. Schnell FM. Chemotherapy-induced nausea and vomiting: the importance of acute antiemetic control. Oncologist. 2003;8:187-198.
3. Lindley CM, Bernard S, Fields SM. Incidence and duration of chemotherapy-induced nausea and vomiting in the outpatient oncology population. J Clin Oncol. 1989;7:1142-1149.
4. 3 receptor antagonists: an overview of their present status and future potential in cancer therapy-induced emesis. Drugs. 1991;42:551-568.
5. 3 receptor antagonists in the treatment of acute chemotherapy-induced nausea and vomiting. Cancer Invest. 2000;18:163-173.
6. Hesketh PJ, Gandara DR. Serotonin antagonists: a new class of antiemetic agents. J Natl Cancer Inst. 1991;83:613-620.
7. American Society of Health-System Pharmacists. ASHP therapeutic guidelines on the pharmacologic management of nausea and vomiting in adult and pediatric patients receiving chemotherapy or radiation therapy or undergoing surgery. Am J Health-Syst Pharm. 1999;56:729-764.
8. Gralla RJ, Osoba D, Kris MG, et al, for the American Society of Clinical Oncology. Recommendations for the use of antiemetics: evidence-hased, clinical practice guidelines. J Clin Oncol. 1999;17:2971-2994.
9. National Comprehensive Cancer Network. Antiemesis. NCCN Clinical Practice Guidelines in Oncology v.1 2005. Available at: http://www.nccn.org. Accessed December 2005.
10. Perugia International Cancer Conference VII. Multinational Association for Supportive Care in Cancer. Consensus Conference on Antiemetic Therapy. Perugia 2004 antiemetic guidelines; updated September 1, 2005. Available at: http://www.mascc.org. Accessed December 2005.
11. Aapro MS, Bertoli L, Lordick F, Bogdanova NV, Macciocchi A. Palonosetron (PALO) is effective in preventing acute and delayed chemotherapy-induced vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC) [abstract A-17]. Supp Care Cancer. 2003;11:391.
12. 3 receptor antagonist: results of a phase III, single-dose trial versus dolasetron. Cancer. 2003;98:2473-2482.
13. Gralla R, Lichinitser M, Van der Vegt S, et al. Palonosetron improves prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy: results of a double-blind randomized phase III trial comparing single doses of palonosetron with ondansetron. Ann Oncol. 2003;14:1570-1577.
14. Hunt TL, Gallagher SC, Cullen MT Jr, Shah AK. Evaluation of safety and pharmacokinetics of consecutive multiple-day dosing of palonosetron in healthy subjects. J Clin Pharmacol. 2005;45:589-596.
15. Eisenberg P, MacKintosh FR, Ritch P, Cornett PA, Macciocchi A. Efficacy, safety, and pharmacokinetics of palonosetron in patients receiving highly emetogenic cisplatin-based chemotherapy: a dose-ranging clinical study. Ann Oncol. 2004;15:330-337.
16. 14C]-palonosetron in healthy human volunteers. Biopharm Drug Dispos. 2004;25:329-337.
17. Tonini G. New drugs for chemotherapy-induced nausea and vomiting: focus on palonosetron. Expert Opin Drug Metab Toxicol. 2005;1:143-149.