Phase I Pilot Study with OXP001 in Healthy Adult Volunteers(QCL117412)
Research type
Research Study
Full title
A Two-Part, Randomised, Open-Label, Evaluator-Blinded, Multiple-Dose, Phase I Pilot Study with OXP001 Ibuprofen 400 mg Tablets and Brufen® 400 mg Tablets to Assess the Comparative Bioavailability (Part 1) and Effects on Gastroduodenal Irritation (Part 2) in Normal, Healthy, Adult, Human Subjects
IRAS ID
166456
Contact name
Sheryl Caswell
Contact email
Sponsor organisation
Oxford Pharmascience Group Plc
Eudract number
2014-004276-38
Duration of Study in the UK
0 years, 2 months, 24 days
Research summary
Oxford Pharmascience Ltd (the Sponsor) is developing a new formulation of ibuprofen (the study drug, OXP001) for the potential treatment of rheumatic and painful conditions. It is proposed that OXP001 will have fewer side effects than are currently reported with standard prescription strength ibuprofen.
The study will compare the study drug to an already marketed formulation of prescription strength ibuprofen (Brufen® - the reference product) by looking at how the drug is taken up by the body and also by performing a specialist procedure called an endoscopy (or more specifically, a gastroscopy). The safety and tolerability of the study drug will also be assessed.
The study will consist of 2 parts involving up to 54 healthy male and female subjects. Subjects will be randomly assigned to receive either the study drug or reference product. Part 1 will be a cross over study in which up to 10 subjects will receive a single dose of 800 mg study drug OXP001 or Brufen® on Day 1, then a single dose of 800 mg study drug OXP001 or Brufen® on Day 4. Part 1 will assess bioavailability and involve an interim decision on progression to Part 2. In Part 2, up to 44 subjects will receive a dose of 800 mg OXP001 or Brufen® three times daily for 7 days in order to assess pharmacokinetics and stomach irritation using endoscopy.
REC name
Wales REC 2
REC reference
14/WA/1167
Date of REC Opinion
3 Dec 2014
REC opinion
Further Information Favourable Opinion