Cross-over study with TK-621R in healthy Japanese male volunteers

• Research type

  Research Study

• Full title

  An Open-Label, Single-Dose, Randomized, Three-Period, Cross-Over Bioequivalence Study of TK-621R 16.8mg, TK-621R 2.1mg x 8 and Durotep® MT Patch 16.8mg in Healthy Japanese Male Volunteers

• IRAS ID

  74963

• Contact name

  Ulrike Lorch

• Sponsor organisation

  Teikoku Seiyaku Co. Ltd.

• Eudract number

  2011-000545-20

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Pain is an unpleasant experience associated with damage to our body. Pain can be useful and nescessary not to involuntarily hurt ourselves . However, many diseases and surgical procedures are associated with sometimes unbearable pain and it is therefore necessary to use substances that can supress pain. There are different types of pain killers e.g. mild such as paracetamol to those made from opiates which are very strong, normally used post-operatively or for severe cancer pain. The active ingredient in the study drug is Fentanyl. Fentanyl was developed in the 1960s and has been used as a strong painkiller, being both safe and effective. Chronic pain treatment by continuous administration is necessary and can be achieved by using transdermal patches (plasters containing a certain amount of medication) is released through the skin over time. The transdermal route of medication administration would be beneficial for patients where swallowing or intravenous injections is difficult or unacceptable. The main aim of the study is to see how the study drug (TK-621R) is handled by the body in comparison to Durotep© MT patch, to investigate how well healthy Japanese male volunteers tolerate the different types of patches. This is a single centre study and will be performed in two parts. Stage 1 will involve 30 healthly Japanese males. Stage 2 will involve 40 healthly Japanese males. Each volunteer will receive three different treatments: TK-621R (16.8 mg x 1 patch), TK-621R (2.1 mg x 8 patches), Durotep© MT patch (16.8 mg x 1 patch). The treatments include the same amount of Fentanyl. There will at least 192 hours of wash-out period between the different treatments. If the objectives are met in Stage 1, then Stage 2 will not be conducted. The assessments and procedures in Stage 2 are the same as that of Stage 1.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  11/IE/0003

• Date of REC Opinion

  3 Mar 2011

• REC opinion

  Further Information Favourable Opinion