EUCTR2016-001055-50-SE进行中（未招募）1 期
A, single center, controlled, multiple dose, randomized study during two weeks, investigating the effect of the test formulation on efficacy, safety and markers for appetite regulation, glucose and lipid absorption and metabolism and body composition, in comparision with Xenical.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. Male subjects age = 24years, = 60 years inclusive.
- •2. BMI 33 – 40 kg/m2 or BMI 30-32 kg/m2 together with waist circumference above 102 cm
- •3. Acceptable medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator. ?
- •4. Adequate renal function: Creatinine < 1.5 times upper limit of normal.
- •5. Adequate hepatic function: ASAT, ALAT, ALP and GGT < 2.5 times upper limit of normal and bilirubin <1.5 times upper limit of normal.
- •6. Adequate glucose control (previous not been diagnosed with diabetes Type II)
- •7. Willing and able to give written informed consent for participation in the study
- •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 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study.
- •2.Any significant medical/surgical procedure or trauma within four weeks of the first administration of IMP, at the discretion of the Investigator.
- •3.Any planned major surgery within the duration of the study.
- •4.High blood pressure (Above 155/95 mmHg)
- •5.No medication with drugs affected by or that affect orlistat and acarbose are allowed 2 weeks before the administration of the IMP
- •6.Known hypersensitivity to any of the test substances.
- •7.Gastrointestinal problems / diseases, e.g. inflammatory bowel diseases and Irritable bowel syndrome
- •8.Cholestasis
- •9.Previous bariatic surgery
- •10.Previous gallbladder surgery
- •11.Previous gastrointestinal surgey that might influence gastrointestinal function significantly..
- •12.Chronical malabsorptionsyndrom
- •13.Vitamin B12 deficiecy or other signs of achlorhydria
- •14.Clinically significant abnormal laboratory values
- •15.History of severe allergic, cardiac, or hepatic disease
- •16.A personal or family history of Medullary Thyroid Carcinoma (MTC)
- •17.A personal or family history of Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- •18.Shift work within 3 weeks before visit 2.
- •19.Excessive intake of alcohol, as judged by the Investigator
- •20.Current or history of alcohol abuse and/or use of anabolic steroids or drugs of abuse.
- •21.Positive screen for drugs of abuse at screening or on admission to the unit or. ?
- •22.Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV).
- •23.Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the three months prior to screening. ?
- •24.Administration of another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within three months of the first administration of IMP in this study. Subjects consented and screened but not dosed in previous studies are not excluded. ?
- •25.Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.
- •26.Engaged in high volume physical exercise, as defined as regular high intensity physical activity (defined as greater than 70% of the maximal pulse rate for 30 min or more) with a total weekly duration of more than 120 min/week.
- •27.Bile acid malabsorption
研究者
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