Bioequivalence of TK-641 vs Oxycontin® Version 1

• Research type

  Research Study

• Full title

  A pivotal, two-way crossover, single dose, open label bioequivalence study of TK-641 40 mg versus OxyContin® 40 mg modified release tablets in healthy male and female Japanese volunteers(Fasting)

• IRAS ID

  7257

• Contact name

  Daryl Bendel

• Sponsor organisation

  TEIKOKU SEIYAKU Co.,Ltd.

• Eudract number

  2008-005269-74

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Japanese pharmaceutical company who has a license of controlled drug which is being developed by a company in Europe would like to market it in Japan. In order to do so, we need to confirm that their drug is absorbed by the body in Japanese subjects in the similar way when compared to the same drug in different formulation that is already marketed in Japan. We??re doing this study to find out whether there are any difference in Japanese people how much of the study medicines get into the bloodstream, and how long does the body take to get rid of them, when they are dosed the test drug and already marketed drug in Japan. We also find out whether there are any important side effects. 24 healthy Japanese subjects will be enrolled in this trial, which consists of 2 study periods of 3 nights and 4 days. CRO company called InCROM Europe will recruit the Japanese healthy volunteers and conduct this trial on behalf of the Japanese sponsor who is funding this research.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  08/H0717/59

• Date of REC Opinion

  7 Nov 2008

• REC opinion

  Further Information Favourable Opinion