Sodium Ibuprofen BE study

• Research type

  Research Study

• Full title

  An open-label, randomised, two-way cross-over, single dose, single centre study in 28 healthy adult volunteers of both sexes to evaluate the pharmacokinetic bioequivalence of 400 mg Ibuprofen from the test Ibuprofen Sodium Powder for Oral Solution, and reference Ibuprofen Lysine Caplets under fasting conditions

• IRAS ID

  165126

• Contact name

  Girish Sharma

• Contact email

  girish.sharma@simbec.co.uk

• Eudract number

  2013-004797-10

• Duration of Study in the UK

  0 years, 2 months, 5 days

• Research summary

  This is a single-centre, randomised, open label, two-way cross-over, single-dose study, in 28 healthy male and female volunteers to evaluate the bioequivalence of 400 mg ibuprofen from Ibuprofen Sodium Powder for Oral Solution (test IMP)and Ibuprofen Lysine Caplets (reference IMP).

  In order to provide clinical evidence of bioequivalence, each subject will receive a single dose of Ibuprofen Sodium Powder for Oral Solution (test IMP) and a single dose of Ibuprofen Lysine Caplets (reference IMP) over two treatment periods (1 dose/period) and plasma concentrations of ibuprofen will be measured to assess the pharmacokinetics (PK) profile of each treatment.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  14/SC/1363

• Date of REC Opinion

  19 Nov 2014

• REC opinion

  Favourable Opinion