Pilot Study of OXP001(2) and Brufen in Healthy Subjects
Status:
Completed
Trial end date:
2015-09-01
Target enrollment:
Participant gender:
Summary
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.