A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage Forms

GlaxoSmithKline Consumer Healthcare0 sitesApril 29, 2009

Overview

No summary available.

Registry

who.int

Start Date

April 29, 2009

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

GlaxoSmithKline Consumer Healthcare

•1\. Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
•2\. Age: Aged 18\-60 years inclusive.
•3\. Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions.
•4\. General Health: Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination.
•5\. Body Weight: The Body Mass Index (BMI) is within the range 25\-33 kg/m2 inclusive.
•6\. Contraception: Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range

•1\. Pregnancy: Women who are pregnant or who have a positive serum pregnancy test.
•2\. Breast\-feeding: Women who are breast–feeding.
•3\. Disease
•a) History of gastro\-intestinal (GI) disease (e.g. irritable bowel disease, chronic or current diarrhoea, inflamed bowel, steatorrhoea/fat malabsorption, current hemorrhoids, incontinence).
•b) History of psychological disease.
•c) History of surgery for weight loss.
•d) History of organ transplant.
•4\. Virology: Seropositive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
•5\. Medications
•a) Previous Xenical® (orlistat) use within 1 month prior to screening.