Project Nico Pharmacokinetic Study

• Research type

  Research Study

• Full title

  An open-label, multiple dose, single centre, bioavailability study of an ibuprofen topical patch in healthy male and female adult volunteers.

• IRAS ID

  120387

• Contact name

  Simon Singer

• Sponsor organisation

  Reckitt Benckiser Healthcare (UK) Limited

• Eudract number

  2012-005023-32

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  This study aims to generate data on the blood levels of Ibuprofen (200mg) when it is administered as a medicated plaster once daily over a period of 5 days in healthy males and females. 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 has developed a locally applied, locally acting ibuprofen topical patch (medicated plaster) for over-the-counter (OTC) treatment of non-serious, localised pain in the adult population. The main purpose of this study is to measure the blood levels of ibuprofen from the topical patch and amount of drug left in the patch after administration.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  13/EE/0017

• Date of REC Opinion

  6 Feb 2013

• REC opinion

  Further Information Favourable Opinion