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

GlaxoSmithKline Consumer Healthcare0 sitesOctober 16, 2007

Overview

No summary available.

Registry

who.int

Start Date

October 16, 2007

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

GlaxoSmithKline Consumer Healthcare

•1\) Age: Aged 18\-60 years inclusive.
•2\) General Health: Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination.
•3\) Body Weight: Body Mass Index (BMI) within the range 25\-33 kg/m2 inclusive.
•4\) Contraception: Females of childbearing potential must, in the opinion of the investigator, be practising a reliable method of contraception.
•5\) Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions including the requirement to be confined to the study site for 37 days.
•6\) 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.
•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, diarrhea, inflamed bowel, steatorrhea/fat malabsorption, hemorrhoids, incontinence).
•(b) History of psychological disease.
•(c) History of surgery for weight loss.
•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.
•(b) Currently taking medication or supplements that influence intestinal transit time and other stool formation parameters or influences cramping (e.g., Anticholinergics (such as atropine) or cholinergics (such as physostigmine), phenothiazines, tricyclic antidepressants, opioid analgesics (including loperamide), calcium channel antagonists, clonidine, cisapride, octreotide. Also, any laxative or antidiarrheal product).