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

This study has been completed.
Sponsor:
Collaborator:
Quotient Clinical
Information provided by (Responsible Party):
Oxford Pharmascience Ltd
ClinicalTrials.gov Identifier:
NCT02521207
First received: August 5, 2015
Last updated: October 27, 2015
Last verified: October 2015
  Purpose

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.


Condition Intervention Phase
Gastroduodenal Erosions Drug: Ibuprofen Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Oxford Pharmascience Ltd:

Primary Outcome Measures:
  • Part 1: Comparison of Peak Plasma Concentration (Cmax) [ Time Frame: Part 1; Day 1 and Day 4 ]
  • Part 2: Comparison of Average Lanza Score [ Time Frame: Part 2; Day 8 ]
  • Part 2: Comparison of Average Number of Erosions [ Time Frame: Day 8 ]
  • Part 1: Comparison of Area Under the Curve (AUC) [ Time Frame: Part 1; Day 1 and Day 4 ]

Enrollment: 53
Study Start Date: July 2015
Study Completion Date: September 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1 OXP001
OXP001 formulation containing 800mg ibuprofen single dose
Drug: Ibuprofen
Active Comparator: Part 1 Ibuprofen control
Ibuprofen control 800mg single dose
Drug: Ibuprofen
Experimental: Part 2 OXP001
OXP001 formulation containing 800mg ibuprofen three times per day
Drug: Ibuprofen
Experimental: Part 2 Ibuprofen control
Ibuprofen control 800mg three times per day
Drug: Ibuprofen

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02521207

Locations
United Kingdom
Quotient Clinical Ltd
Nottingham, Notts, United Kingdom, NG11 6JS
Sponsors and Collaborators
Oxford Pharmascience Ltd
Quotient Clinical
Investigators
Principal Investigator: Stuart Mair Quotient Clinical Ltd
  More Information

Responsible Party: Oxford Pharmascience Ltd
ClinicalTrials.gov Identifier: NCT02521207     History of Changes
Other Study ID Numbers: OXP001-003
Study First Received: August 5, 2015
Last Updated: October 27, 2015

Additional relevant MeSH terms:
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 21, 2017