A study to investigate a new paracetamol and caffeine tablet (v1)

• Research type

  Research Study

• Full title

  A single dose pharmacoscintigraphic study investigating the differences in gastrointestinal behaviour and paracetamol absorption between two paracetamol formulations

• IRAS ID

  43090

• Contact name

  HNE Stevens

• Sponsor organisation

  GlaxoSmithKline Consumer Healthcare (GSKCH)

• Eudract number

  2009-017590-38

• Research summary

  GSKCH has developed a new tablet containing paracetamol and caffeine. Paracetamol is a widely used painkiller while caffeine has been shown to improve headache relief when given in a tablet together with paracetamol. The tablet is designed to dissolve faster in comparison to conventional tablets. This study has been designed to compare this new tablet with a paracetamol tablet which is currently available on the market, Panadol. Both tablets are capsule-shaped tablets, similar to the kind which may be taken for a headache. We will be looking at: * when and where the tablets start to break up in the body * when and where the tablets have completely broken up in the body * the blood levels of the drug, paracetamol To look at these parameters we will add small amounts of radioactive material to the tablets. The radiation emitted will be detected outside the body by a device known as a gamma camera. We will also take blood samples to allow us to measure the levels of the drug in the bloodstream. Only healthy male volunteers will be recruited into this study, which may last approximately 8 weeks from initial screening to final post-study medical.

• REC name

  East of Scotland Research Ethics Service REC 1

• REC reference

  10/S1401/2

• Date of REC Opinion

  12 Mar 2010

• REC opinion

  Further Information Favourable Opinion