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临床试验/NCT01170806
NCT01170806已完成不适用

Study of Pharmacodynamic Equivalence of Two Commercial Formulations of Orlistat (Lipiblock vs Xenical) on Intestinal Lipases Inhibition

University of Campinas, Brazil1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2009年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Study of equivalence between two commercial capsules of Orlistat on fat absorption inhibition

研究概览

简要总结

Obesity is a chronic condition with fat-rich diets playing a major role in its etiology. Pharmacological therapy has been proposed for weight loss and maintenance. This study aims to study the intestinal lipase blockade by partial inhibition of fat absorption after treatment with two commercials formulations of Orlistat.

详细描述

The overweight and obesity epidemic affects approximately 1.6 millions of people worldwide. Obesity is a chronic condition, associated with premature death, co-morbidities, risk factors for main cardiac disease, stigmatization and significant economic costs. The causes of obesity are complex and include the interplay of environmental, social, economic and genetic factors. Besides fat-rich diets also play a significant role in the etiology of obesity. Correct diet orientation associated with physical exercise usually did not lead to expected result in weight loss and maintenance. Pharmacological therapy has been proposed as an adjunct to achieve the ideal weight. Orlistat acts in reduction of lipids absorption by inhibition of gastric and pancreatic lipases in gastrointestinal tract leading to sustained weight loss. This is a double blind study, randomized, of 2 weeks. The aim of this study was evaluate the intestinal lipase blockade by decrease of fat absorption of fecal fat after treatment with two commercials formulations of Orlistat in obese patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • BMC (Body Mass Index) between 30 to 40 kg/m2
  • 18 to 45 years
  • Premenopausal stage

排除标准

  • Relevant diseases (diabetes, cardiovascular, gastrointestinal, renal and hepatic diseases, endocrine disorders, hemoglobinopatHy or neoplasm in the last three years)
  • Chemical or natural laxatives
  • Weight variation greater than 5% in the preceding 3 months
  • Surgery for weight reduction
  • Drugs to obesity control and/or oral corticosteroids anti-inflammatory in the last three months

研究组 & 干预措施

Orlistat (Lipiblock) treatment

Active Comparator

Lipiblock is a new Orlistat formulation, produce by Germed Pharma, Brazil. Capsule 120mg

干预措施: Orlistat (Drug)

Orlistat (Xenical) treatment

Active Comparator

Xenical is a innovator Orlistat formulation, produced by Roche

干预措施: Orlistat (Drug)

结局指标

主要结局

Study of equivalence between two commercial capsules of Orlistat on fat absorption inhibition

时间窗: baseline

This study aim to investigate differences in fat absorption inhibition after 7 days treatment with Lipiblock and Xenical (two commercial capsules of Orlistat). Therefore, total fecal fat and fecal fat percentage wil be analysed, comparing these data before and after treatment with Lipiblock and Xeical.

次要结局

  • Study of equivalence between two commercial capsules of Orlistat on fat absorption inhibition(after 7 days Orlistat treatment)

研究者

发起方
University of Campinas, Brazil
申办方类型
Other

研究点 (1)

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