QCL117079 Phase I Study with OXP005 and Naprosyn

• Research type

  Research Study

• Full title

  An Open-Label, Single-Dose, Randomised, Two-Way Crossover Study to Assess the Comparative Bioavailability and Pharmacokinetics of Naproxen from OXP005 250 mg Tablets (Test) And Naprosyn® 250 mg Tablets (Reference) in Normal, Healthy, Adult Subjects

• IRAS ID

  168573

• Contact name

  Sheryl Caswell

• Contact email

  sheryl.caswell@pharmascience.co.uk

• Sponsor organisation

  Oxford Pharmascience Ltd

• Eudract number

  2014-004863-19

• Duration of Study in the UK

  0 years, 1 months, 6 days

• Research summary

  The Sponsor is developing a new form of naproxen (the study drug, OXP005), for the potential treatment of rheumatic and painful conditions.

  The study will compare the study drug to an already marketed formulation of prescription strength naproxen (Naprosyn® - the reference product) by looking at how a single dose of the drug is taken up by the body. The safety and tolerability of the drug will also be assessed.

• REC name

  Wales REC 2

• REC reference

  15/WA/0005

• Date of REC Opinion

  22 Jan 2015

• REC opinion

  Favourable Opinion