Pilot Study of OXP001(2) and Brufen in Healthy Subjects
- Registration Number
- NCT02521207
- Lead Sponsor
- Oxford Pharmascience Ltd
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1 Ibuprofen control Ibuprofen Ibuprofen control 800mg single dose Part 2 OXP001 Ibuprofen OXP001 formulation containing 800mg ibuprofen three times per day Part 2 Ibuprofen control Ibuprofen Ibuprofen control 800mg three times per day Part 1 OXP001 Ibuprofen OXP001 formulation containing 800mg ibuprofen single dose
- Primary Outcome Measures
Name Time Method Part 1: Comparison of Peak Plasma Concentration (Cmax) Part 1; Day 1 and Day 4 Part 2: Comparison of Average Lanza Score Part 2; Day 8 Part 2: Comparison of Average Number of Erosions Day 8 Part 1: Comparison of Area Under the Curve (AUC) Part 1; Day 1 and Day 4
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Quotient Clinical Ltd
🇬🇧Nottingham, Notts, United Kingdom