Study in Healthy Males to Evaluate Novel Celecoxib Formulation(117779)
Research type
Research Study
Full title
A Phase 1 Study in Healthy Male Subjects to Evaluate the Pharmacokinetics of the Novel Celecoxib Powder in Bottle Formulation and the Effect of Food.
IRAS ID
205969
Contact name
Katalin Ferenczi
Contact email
Sponsor organisation
Druggability Technologies Holdings Ltd
Eudract number
2016-001218-11
Duration of Study in the UK
0 years, 2 months, 3 days
Research summary
The Sponsor is developing a novel formulation of the study drug, Celecoxib, for the treatment of pain relief. \n\nThe study will try to identify if changes in the formulation of the study drug will have a notable effect on the absorption rate of the study drug. Increase in the absorption rate would allow plasma concentrations necessary for the onset of action to be reached quicker, thereby delivering earlier pain relief.\n\nThe study will consist of up to 3 study periods involving up to 12 healthy male subjects. In Period 1 (Regimen A), subjects will receive a dose of 200 mg study drug in the fasted state. In Period 2 (Regimen B) subjects will receive either 50/100/150 mg administered in the fasted state or 200mg in the fed state. Period 3 (Regimen C) is an optional period in which subjects will receive 50/100/150 mg in the fed state.\n
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
16/EE/0206
Date of REC Opinion
12 Jul 2016
REC opinion
Further Information Favourable Opinion