To assess the Pharmacodynamic Equivalence of Two Orlistat Dosage Forms
Research type
Research Study
Full title
A Study to Assess the Pharmacodynamic Equivalence of Two Orlistat Dosage Forms
IRAS ID
62505
Contact name
johnston stewart
Sponsor organisation
Salford Royal Foundation Trust
Eudract number
2010-022411-19
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
Orlistat works in the body to prevent fat being absorbed from food. The main purpose of this study is to look at the effect on the body that a new 27 mg chewable tablet form of orlistat has compared with a 60 mg dose and a 120 mg dose of a currently marketed 60 mg capsule form. To study this, the amount of fat excreted from the body in faeces (??stools?Â) will be measured. The number and intensity of commonly observed adverse events (changes in normal health) will also be looked at. A total of up to 144 male and/or female volunteers (aged 18-60 years inclusive) will take part in this study. Each of the 3 treatments given will be administered 3 times a day for 9 consecutive days. There will be a 2 day washout interval between treatments. The maximum duration of the study from screening until finishing the confinement period for each volunteer could be up to 65 days.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
10/IEC04/21
Date of REC Opinion
14 Sep 2010
REC opinion
Further Information Favourable Opinion