ACTRN12611001254987已完成4 期
Effects of SLCO1B1 Polymorphism and Pitavastatin on the Pharmacokinetics of Repaglinide in Chinese Healthy Volunteers
Third Xiangya Hospital, Central South University0 个研究点目标入组 12 人开始时间: 2011年12月7日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Educational / counselling / training
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- Male
入选标准
- •1) Subjects must be able to read and understand the contents of informed consent,and signed informed consent;
- •2) Age 18-55 years old, male, no more than 10 years in age difference with the same batch (including the boundary values);
- •3) Body weight > 50kg, the subjects body mass index (BMI) between 19-25kg/m2 (BMI = weight (kg) / height 2 (m2)), including the boundary values, the same batch weight difference should not be great;
- •4)No history of alcohol abuse or drug abuse, non-smokers;
- •5) They are ascertained to be healthy by physical examination such as blood pressure, heart rate, ECG, respiratory status, liver and kidney function and so on;
- •6) Subjects can be able to make good communication with researchers and complete research in accordance with the provisions of study.
排除标准
- •1)It is known that there are allergies for active pharmaceutical ingredients or excipients;
- •2) Specific allergic history (asthma, urticaria, eczema, dermatitis), arrhythmia, bradycardia, hypotension, coronary heart disease, bronchial and cardiovascular diseases, diabetes, hyperthyroidism, Parkinson's disease, epilepsy , tremor, paralysis and any other diseases or physiological conditions interfering test results;
- •3) Subjects are receiving or have been received gastrointestinal problems, seizures, gastrointestinal ulcers, urinary tract infarction, mechanical intestinal obstruction, ureteral spasm, biliary tract disease and other treatment of depressive disorders or liver disease;
- •4) It is known that the factors can affect the venous blood of severe bleeding;
- •5) Some gastrointestinal tract diseases can affect drug absorption or metabolism;
- •6) Subjects have the history of drug abuse or positive urine drug test results within the past five years;
- •7) The combined use of drugs that affect glucose metabolism, such as corticosteroids and so on;
- •8) It is known to have used drugs that damage an organ within three months;
- •9) It is known to have used other drugs that may affect the metabolism of hypoglycemic drugs within 14 days before the test (such as monoamine oxidase inhibitors, non-selective ß-blockers, ACEI, non-steroidal anti-inflammatory drugs, salicylates, octreotide , alcohol, anabolic growth hormone, oral contraceptives, thiazide drugs, corticosteroids, danazol, thyroid hormones, sympathomimetics, ketoconazole, itraconazole, erythromycin, fluconazole, and other azole anti-fungal, rifampicin, phenytoin, trimethoprim, cyclosporine, macrolide antibiotics erythromycin and clarithromycin, cimetidine, indomethacin,etc);
- •10) A serious loss of blood or donating blood or plasma (300mL) within 30 days before the test;
- •11)Primary disease in vital organs;
- •12)Regular smokers or drinkers, that drinking more than 28 units of alcohol per week (1 unit: 285ml beer or 1 glass of wine or 25ml spirits) or weekly smoking over two or more cigarette;
- •13) Often using sedatives, sleeping pills, tranquilizers or other addictive drugs;
- •14) The researchers believe that some subjects should not be included.
研究者
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