A Pharmacokinetic Study of Two Oral Formulations of Orlistat

• Research type

  Research Study

• Full title

  A Pharmacokinetic Study of Two Oral Formulations of Orlistat

• IRAS ID

  38458

• Contact name

  Johnston Stewart

• Sponsor organisation

  GlaxoSmithKline Consumer Healthcare

• Eudract number

  2009-017156-27

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  Orlistat works in the body to prevent fat being absorbed from food. The new 27 mg chewable tablet formulation of orlistat that is being tested in this study has been shown in previous studies to work in the body to the same extent as the currently marketed alli© 60 mg capsule. This study is being carried out to compare the amount of orlistat and its breakdown products (M1 and M3) that get into the blood stream following administration of the new chewable tablet and the currently marketed capsule. This study will also look at the number and intensity of commonly observed adverse events (changes in normal health). A total of up to 22 male and/or female volunteers (aged between 18-60 years) will take part in this study. All volunteers will be required to eat a set low-fat diet containing no more than 30% fat from admission to the clinic on the day before the first dose until study completion (total of 8 days). Volunteers will be randomly assigned (picked by chance) to receive each of the two study products over 2 days on 2 separate occasions (5 doses of each study product making a total of 10 doses over the course of the study). Each dose will be given with a meal. There will be an interval of 3 days between each assessment period when no study drug will be given but volunteers will be asked to stay at the clinic. The maximum duration of the study from screening until finishing the confinement period for each volunteer could be up to 22 days. This is one of a number of studies being performed during the development of a new formulation of orlistat.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  09/H0304/90

• Date of REC Opinion

  21 Jan 2010

• REC opinion

  Further Information Favourable Opinion