Bioequivalence of TK-641 vs Oxycontin® in a fed state 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 in a fed state

• IRAS ID

  7950

• Contact name

  Daryl Bendel

• Sponsor organisation

  TEIKOKU SEIYAKU Co.,Ltd.

• Eudract number

  2008-005270-12

• 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 after, when they are dosed the test drug and already marketed drug in Japan under fed conditions. 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/H0717/60

• Date of REC Opinion

  28 Oct 2008

• REC opinion

  Further Information Favourable Opinion