Pilot Study of OXP001 and Brufen in Healthy Subjects
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- Gastric irritation as measured by a Lanza score [ Time Frame: 7 days ]
- 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 ]
|Study Start Date:||February 2014|
|Study Completion Date:||April 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Ibuprofen
Other Name: Brufen
Please refer to this study by its ClinicalTrials.gov identifier: NCT02050958
|Nottingham, United Kingdom|
|Principal Investigator:||Stuart Mair, MB ChB||Quotient Clinical Ltd|