Pharmacokinetic study to assess the behaviour of granisetron

• Research type

  Research Study

• Full title

  A Phase I study to evaluate the effect of heat on the pharmacokinetics of transdermal granisetron in healthy subjects (Quotient Study No:104099)

• IRAS ID

  45223

• Contact name

  Stuart J Mair

• Sponsor organisation

  Strakan Pharmaceuticals Limited

• Eudract number

  2009-017036-40

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The medicine being tested in this study is called the granisetron transdermal delivery system (Sancuso©) or the granisetron patch. Sancuso is a medicine used to prevent nausea and vomiting in people receiving some types of chemotherapy treatment of up to 5 days duration. Several clinical studies and case reports have shown that heat can increase drug absorption from transdermal patches. Since Sancuso© is a transdermal patch formulation there is a risk that granisetron absorption could be increased by heat. This study is designed to provide information on the effects of heat on the pharmacokinetics of transdermal granisetron. Potential sources of heat in this population include heat pads, showers, saunas, jacuzzis and the sun. The heat source used in this study will be Cura-Heat with a therapeutic temperature of approximately 42§C (107.6§F), hereafter referred to as Cura-Heat.

• REC name

  Scotland A REC

• REC reference

  10/IEC02/2

• Date of REC Opinion

  15 Feb 2010

• REC opinion

  Further Information Favourable Opinion