Pilot Study of OXP001(2) and Brufen in Healthy Subjects

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Oxford Pharmascience Ltd
• Collaborator: Quotient Clinical
• Treatments: Ibuprofen

Criteria

Inclusion Criteria:

• Healthy male or female subject

• Healthy, normal upper GI tract as indicated by no ulcers or erosions at baseline, as assessed by the gastroenterologist conducting the endoscopy (ie Lanza score of 0 in both the stomach and duodenum) (Part 2 only)

• H. pylori negative

Exclusion Criteria:

• Clinically significant abnormal laboratory parameters

• Any clinically significant diseases or conditions affecting the haematopoietic, cardiovascular, renal, hepatic, endocrine, pulmonary, central nervous, immunological, dermatological, GI or any other body system