Ibuprofen and pseudoephedrine BA Study

• Research type

  Research Study

• Full title

  An open-label, randomised, three-way cross-over, single dose, single centre study to evaluate the relative bioavailability between ibuprofen and pseudoephedrine liquid capsules (2x 200 mg ibuprofen & 30 mg pseudoephedrine) (test), ibuprofen and pseudoephedrine tablets (2x 200 mg ibuprofen & 30 mg pseudoephedrine) (comparator 1), and ibuprofen liquid capsules (2x 200 mg solubilised ibuprofen) (comparator 2).

• IRAS ID

  172327

• Contact name

  Robert Adams

• Contact email

  robert.adams@simbec.com

• Eudract number

  2014-000840-14

• Duration of Study in the UK

  0 years, 2 months, 0 days

• Research summary

  This is an open-label, randomised, three-way cross-over, single dose, single centre study to evaluate the relative bioavailability between ibuprofen and pseudoephedrine liquid capsules (2x 200 mg ibuprofen & 30 mg pseudoephedrine) (test), ibuprofen and pseudoephedrine tablets (2x 200 mg ibuprofen & 30 mg pseudoephedrine) (comparator 1), and ibuprofen liquid capsules (2x 200 mg solubilised ibuprofen) (comparator 2).

  In order to provide clinical evidence of bioavailability, each subject will receive a single dose of ibuprofen and pseudoephedrine liquid capsules, ibuprofen and pseudoephedrine tablets and ibuprofen liquid capsules on separate dosing days orally. Plasma concentrations of ibuprofen and pseudoephedrine will be measured to assess the pharmacokinetics (PK) profile of each treatment.

• REC name

  Wales REC 2

• REC reference

  15/WA/0033

• Date of REC Opinion

  5 Mar 2015

• REC opinion

  Further Information Favourable Opinion