2-way crossover, Nurofen suspensions

• Research type

  Research Study

• Full title

  An open-label, 2-way crossover, randomised, single dose, single centre study in healthy adults to compare the bioavailability of ibuprofen from a 2% w/v suspension (Nurofen for Children®; 20 mL containing 400 mg ibuprofen) with that from a 4% w/v suspension (Nurofen for Children®; 10 mL containing 400 mg ibuprofen).

• IRAS ID

  92197

• Contact name

  Girish Sharma

• Sponsor organisation

  Reckitt Benckiser Healthcare (UK) Ltd

• Eudract number

  2011-005087-25

• ISRCTN Number

  1

• Research summary

  Reckitt Benckiser Healthcare have developed a new ibuprofen 4%w/v oral suspension, Nurofen for Children (Ibuprofen 4%w/v oral suspension) has been approved for marketing in 25 countries in Europe and in Australia. Indications and lower age limit vary by market, and include for the short-term treatment of mild to moderate pain and symptomatic treatment of fever in children aged from 3 months to twelve years. In order to support further Marketing Authorisation Applications a study is required to compare the bioavailability of ibuprofen from Nurofen for Children 2%w/v suspension with that from Nurofen for Children 4%w/v suspension. The study will be conducted in healthy adults in order to eliminate the interference in absorption, distribution, metabolism and excretion of ibuprofen that may occur in subjects with an illness. The use of the crossover design minimizes the number of subjects required and is appropriate as the washout period of two to seven days will ensure no carryover effect of previous dosing. Furthermore, the use of adults is justified given the lack of a marked difference between adults and children in the metabolism of ibuprofen and the ethical issues that would be raised by the use of children. The study will use a single dose of 400 mg Nurofen for Children, since this is the recommended maximum non-prescription dose of ibuprofen in adults. The reference product in the current study will be Nurofen for children ibuprofen 2% w/v (20 mg/mL) orange flavoured suspension.

• REC name

  Wales REC 2

• REC reference

  11/WA/0350

• Date of REC Opinion

  9 Dec 2011

• REC opinion

  Favourable Opinion