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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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).
(c) Has taken medication including herbal remedies, for weight loss or appetite control within 4 days prior to commencement of the confinement phase.
(d) Has taken prescription only medications within 14 days prior to the start of the confinement phase. Cyclosporine is specifically contraindicated. Note that oral contraceptives are allowed.
(e) Has taken over the counter medications within 48 hours prior to the start of the confinement phase, apart from paracetamol and topical medications which are allowed throughout the study.
6) Diet:
(a) Currently dieting or otherwise unable to eat food provided during confinement phase.
(b) Food allergies/sensitivities
(c) Has consumed alcohol within 48 hours prior to the start of the confinement phase.
7) Exercise: Heavy physical activity routine (e.g., athletes in training) as the routine would not be maintained during the study.
8) Substance Abuse: Current or recent (within one year of screening) alcohol or other substance abuse.
9) Smokers: Smokers of more than 12 cigarettes per day.
10) Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
11) Clinical Study/Experimental Medication:
(a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
(b) Previous participation in this study.
12) Personnel: An employee of the sponsor or the study site.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To establish the bioequivalence of the 30mg chewable orlistat tablet to the 60mg orlistat capsule.;Secondary Objective: To assess and compare the frequency and intensity of commonly observed Adverse Events (AEs);Primary end point(s): Faecal fat content

Secondary Outcome Measures

Name	Time	Method

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