Nurofen Bioequivalence Study

• Research type

  Research Study

• Full title

  A randomised, single dose, 3 way crossover, open label pharmacokinetic study comparing an ibuprophen 4%, 10 ml oral suspension with the standard sugar coated Nurofen tablet (reference product 2x200mg tablets) and ibuprofen lysine tablet (the comparator product - 2x200mg tablets) in normal healthy volunteers.

• IRAS ID

  88691

• Contact name

  CI Name Simon Singer

• Sponsor organisation

  Reckitt Benckiser Healthcare (UK)

• Eudract number

  2011-004299-12

• Research summary

  Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic (pain killing) and antipyretic (anti temperature) activity which has been available to purchase over the counter since 1983. It is used for the symptomatic treatment of many types of arthritis and it is also prescribed in other post-traumatic inflammatory conditions, as well as mild to moderate pain and fever.The Sponsor company, Reckitt Benckiser Healthcare have developed a new formulation of ibuprofen in the form of a suspension for oral consumption, in which the active ingredient is standard ibuprofen. The main purpose of this study is to compare the blood levels of ibuprofen from the oral suspension with sugar coated ibuprofen tablets and ibuprofen lysine tablets.The main aims of the study are to learn about and compare the rate of absorption of ibuprofen oral suspension (400mg in 10mL) against ibuprofen tablets (2 x 200mg) and ibuprofen lysine tablets (2 x 200mg).

• REC name

  Scotland A REC

• REC reference

  11/IE/0157

• Date of REC Opinion

  12 Oct 2011

• REC opinion

  Further Information Favourable Opinion