Pilot Study of OXP001 and Brufen in Healthy Subjects

Overview

Oxford Pharmascience (the sponsor) is developing a new formulation of Ibuprofen (OXP001 – the study drug) which it is proposed will have less of the side effects than are currently reported with standard prescription strength Ibuprofen. This study will compare the study drug to an already marketed formulation of prescription strength Ibuprofen (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 involve approximately 44 healthy male and female subjects. Subjects will be randomly assigned to receive either the study drug or reference product for 8 days. On Day 1, subjects will receive a single 800 mg dose of ibuprofen. On Days 2 to 9, subjects will receive 800 mg ibuprofen three times a day.

Full Title of Study: “A Randomised, Open Label, Evaluator Blinded, Multiple Dose, Parallel Arm, Phase I Pilot Study of OXP001 Ibuprofen 400 mg Tablets and Brufen 400 mg Tablets in Normal, Healthy, Adult, Human Subjects Under Fasting Conditions to Assess The Incidence of Upper Gastrointestinal Irritation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: March 2014

Interventions

  • Drug: OXP001
  • Drug: Ibuprofen

Arms, Groups and Cohorts

  • Experimental: OXP001
    • OXP001
  • Active Comparator: Ibuprofen
    • Brufen

Clinical Trial Outcome Measures

Primary Measures

  • Gastric irritation as measured by a Lanza score
    • Time Frame: 7 days

Secondary Measures

  • Number of erosions
    • Time Frame: 7 days
  • Number of ulcers
    • Time Frame: 7 days
  • Incidence of gastric irritation
    • Time Frame: 7 days
  • Lanza score in stomach and duodenum
    • Time Frame: 7 days

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy subjects – Aged 18-55 years – Normal, healthy upper gastrointestinal tract Exclusion Criteria:

  • History of or concurrent gastric irritation or ulcers – History of allergy to non-steroidal anti-inflammatory drugs (NSAIDs)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Oxford Pharmascience Ltd
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Stuart Mair, MB ChB, Principal Investigator, Quotient Clinical Ltd

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