JPRN-jRCTs031180125招募中未知
Open-label, Crossover Exploratory Study to Assess the dose-dependent effect of pyrimethamine ON The Pharmacokinetics of Endogenous biomarkers and Probe Drugs for assessment of drug-drug interactions mediated by MATE1/2K - Open-label, Crossover Exploratory Study to Assess the dose-dependent effect of pyrimethamine ON The Pharmacokinetics of Endogenous biomarkers and Probe Drugs for assessment of drug-drug interactions mediated by MATE1/2K
Furihata Kenichi0 个研究点目标入组 12 人开始时间: 2019年2月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 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
入排标准
- 年龄范围
- >= 20age old 至 < 40age old（—）
- 性别
- Male
入选标准
- •a)Healthy Japanese men at >=20 but <40 years of age when the consent was obtained.
- •b)Persons whose body mass index (BMI) is >=18.5 but <25.0 at screening.
- •c)Persons who were judged appropriate as subjects by the investigator (sub-investigator) based on medical history and physical exam and laboratory tests at screening.
- •d)Subjects who can understand and comply with the protocol and from whom the written consent based on his or her own free will can be obtained.
排除标准
- •a) Persons with a history of hypersensitivity to metformin or biguanide drug, pyrimethamine
- •b) Persons who are contraindicated for administration of metformin
- •c) Persons who are in the following state [Persons who are liable to cause lactic acidosis.]
- •(1) history of lactic acidosis
- •(2) renal dysfunction of moderate or higher
- •(3) dialysis patients (including peritoneal dialysis)
- •(4) severe liver dysfunction,
- •(5) shock, heart failure, myocardial infarction
- •(6) excessive alcohol intake
- •(7) Patients with gastrointestinal disorders such as vomiting, dehydration or diarrhea in which dehydration are a concern.
- •-Patients with severe ketosis, diabetic coma or precoma, type 1 diabetes [infusion, correction of rapid hyperglycemia by insulin is essential.]
- •-Severe infection, patients before and after surgery, patients with severe trauma [Administration of this drug is not suitable because it is desired to control blood glucose by insulin injection. Also, it is liable to cause lactic acidosis.]
- •-Patients with malnutrition, starvation, weakness, pituitary dysfunction or adrenal insufficiency
- •[May cause hypoglycemia. ]
- •-Persons who are contraindication of pyrimethamine administration or need careful administration
- •-Patients with megaloblastic anemia based on folate deficiency, patients with blood disorders or previous medical history, people with deficiency of folic acid or abnormal metabolism
- •-Person or parents, brothers who have a constitution prone to allergic symptoms such as bronchial asthma, rash, urticaria, or who have a history of hypersensitivity to other drugs.[Because there is description in interview form of fansidar (a combination agent containing sulphadoxin 500 mg and pyrimethamine 25 mg in 1 tablet, not single agent of pyrimethamine)]
- •d) Persons with lactose intolerance
- •e) Persons with hypotension (systolic blood pressure: <90 mmHg) or hypertension (systolic blood pressure: >=160 mmHg)
- •f) Persons who donated or lost 200 mL (1 unit) of blood within 4 weeks before administration of study drugs or 400 mL (2 units) of blood within 3 months before administration of study drugs.
- •g) Persons with a medical history/complication of severe nerve disease, cerebrovascular disease, liver disease, kidney disease, endocrine disease, cardiovascular disease, gastrointestinal disease (including digestive system disease which is considered to affect the absorption of study drugs), respiratory disease, metabolic disease, and anemia.
- •h) Persons with estimated creatinine clearance (eClcr, Cockcroft-Gault Equation) < 90 mL/min.
- •The person with low renal excretion ability of medicines
- •i) Persons who have been confirmed of a clinically severe abnormality based on medical examination or physical examination by the investigator or subinvestigator.
- •j) Persons with a clinically severe disease within 30 days before administration of study drugs.
- •k) Persons who took drugs, health food including St.John's wort, food 14 days prior to dosing and beverages including grapefruit, orange and apple (including food containing them), and nutritional supplements 7 days prior to dosing and cannot comply with prohibition of taking them during the study.
- •l) Persons who are smoking or taking nicotine within 30 days before administration of study drugs and who cannot comply with smoking cessation during the study period.
- •m) Persons who took alcohol/caffeine-containing food on the day before hospitalization in each study period and cannot comply with p
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