NSAID Related Gastric Irritation Clinical Trial
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment