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?) 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