To investigate the safety and Pharmacokinetics of TK-621 (16.8 mg)

• Research type

  Research Study

• Full title

  An Open-Label, Single-Dose, Randomized, Two-Period, Cross-Over Study to Investigate the Safety, Tolerability and Pharmacokinetics of TK-621 (16.8 mg) in Healthy Caucasian Male Volunteers by Comparison with Durotep® MT Patch (16.8 mg).

• IRAS ID

  11784

• Sponsor organisation

  Teikoku Seiyaku Co.,Ltd.

• Eudract number

  2008-006761-90

• ISRCTN Number

  xx

• Research summary

  The drug being tested in this study is TK-621 a skin patch being developed to help in the treatment of chronic pain. It contains a drug called Fentanyl, one of the most powerful opioid analgesics with a potency approximately 81 times that of morphine and has been widely available for many years on prescription. The objective of this study is to compare a new matrix patch formulation of TK-621 that contains 16.8 mg of fentanyl against Durotep© 16.8 mg matrix patch (currently licensed in Japan) in healthy male volunteers when applied to the skin for 72 hours. The study will take place at Quintiles Limited, Guy's Drug Research Unit. It will involve 12 subjects. For each subject the study will involve 2 admissions periods lasting for 8 days (7 nights).

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  08/H0802/142

• Date of REC Opinion

  13 Jan 2009

• REC opinion

  Further Information Favourable Opinion