E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10047900 |
E.1.2 | Term | Weight loss |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To establish the pharmacologic equivalence of the 27mg chewable orlistat tablet to the 60mg orlistat (alli) capsule based on a two-sided test (TOST) using logarithmic scale of % fecal fat excreted. The dose scale methodology for evaluation of therapeutic equivalence will also be performed in the analysis of therapeutic equivalence. |
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E.2.2 | Secondary objectives of the trial |
To assess and compare the frequency and intensity of commonly observed Adverse Events (AEs). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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.
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E.4 | Principal 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, 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. 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 antidiarrhoeal 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: Current smokers are excluded from participation in this study. Previous smokers should have been abstinent for at least six months. 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 or members of their immediate family.
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Yes |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | Yes |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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last visit of last subject |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 2 |