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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastroduodenal Erosions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Part 1 OXP001

OXP001 formulation containing 800mg ibuprofen single dose

Group Type EXPERIMENTAL

Ibuprofen

Intervention Type DRUG

Part 1 Ibuprofen control

Ibuprofen control 800mg single dose

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

Part 2 OXP001

OXP001 formulation containing 800mg ibuprofen three times per day

Group Type EXPERIMENTAL

Ibuprofen

Intervention Type DRUG

Part 2 Ibuprofen control

Ibuprofen control 800mg three times per day

Group Type EXPERIMENTAL

Ibuprofen

Intervention Type DRUG

Interventions

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Ibuprofen

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes