Gastroduodenal Erosions Clinical Trial
Official 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 Healthy Human Subjects
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02408978 -
Pilot Study of OXP005 to Assess Gastroduodenal Irritation
|
Phase 1 |