A Study Evaluating Safety and Pharmacokinetics of a Single Oral TPN171H in Elderly Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameter of TPN171H:Vd
研究概览
简要总结
It is a single-center, open-label, Phase I clinical study evaluating the safety and pharmacokinetics of a single oral TPN171H in elderly subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 65 years old；
- •Male≥50kg，femal≥45kg, Body mass index should be between 18 and 30 kg/m2 (inclusive)；
- •No major organ dysfunction；normal heart, liver and kidney function;
- •Physical examination, vital signs examination, laboratory examination (blood routine, urine routine, blood biochemistry), 12 lead ECG, Abdominal ultrasound, chest X-ray results were normal or abnormal but investigator judged suitable for participating in this trial;
- •Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent
排除标准
- •Allergies to test preparations, any of their ingredients, and related preparations; With allergies or allergic diseases;
- •Surgical condition or condition that may significantly affect ADME of the drug, urgical condition or condition that may pose a hazard if the subject participating in the study
- •Myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass grafting, congestive heart failure, severe arrhythmias, cerebrovascular accidents, including transient ischemic attack within 3 months before inclusion;
- •Taken any of drugs(Inhibits or induces liver metabolism) within 2 weeks before inclusion；administered with Nitrate/Nitric oxide (NO) donors。
- •With a history of the following ocular diseases: nonvascular anterior ischemic optic neuropathy (NAION), abnormal color vision, hereditary retinopathy (e.g. Retinitis pigmentosa), and macular degeneration；
- •A history of sudden decrease or loss of hearing；
- •A history of postural hypotension；
- •Blood loss ≥400 mL within 3 months before inclusion；
- •Participated in other drug clinical trials or medical devices clinical trials within 3 months before administration；
- •Drink alcohol at least 2 times a day or more than 14 times a week in the 6 months prior to enrollment or alcoholics(Drink alcoholics defined as 125 mL of wine, 220 mL of beer, or liquor50mL； Alcoholism is defined as 5 or more drinks in approximately 2 hours) ;
- •A history of drug use or have been screened positive for drug abuse;
- •Smoked more than 10 cigarettes a day within 6 months prior to inclusion;
- •hepatitis B surface antigen (HBsAg),hepatitis C virus antibody,treponema pallidum antibody,Human immunodeficiency virus antibody (HIV)positive;
- •Other factors that the investigator considered inappropriate for the study.
研究组 & 干预措施
TPN171H
5 mg TPN171H tablets，single dose,oral
干预措施: TPN171H (Drug)
结局指标
主要结局
Pharmacokinetic parameter of TPN171H:Vd
时间窗: 48 hours after dosing
Pharmacokinetic parameter of TPN171H:Vd
Adverse events
时间窗: 7 days after dosing
Number of Participants With treatment-related Adverse Events and Serious Adverse Events
Pharmacokinetic parameter of TPN171H:T1/2
时间窗: 48 hours after dosing
Pharmacokinetic parameter of TPN171H:T1/2
Pharmacokinetic parameter of TPN171H:AUC0-t
时间窗: 48 hours after dosing
Pharmacokinetic parameter of TPN171H:AUC0-t
Pharmacokinetic parameter of TPN171H:Ke
时间窗: 48 hours after dosing
Pharmacokinetic parameter of TPN171H:Ke
Pharmacokinetic parameter of TPN171H:BRPP
时间窗: 48 hours after dosing
Pharmacokinetic parameter of TPN171H:BRPP
Pharmacokinetic parameter of TPN171H:Tmax
时间窗: 48 hours after dosing
Pharmacokinetic parameter of TPN171H:Tmax
Pharmacokinetic parameter of TPN171H:Cmax
时间窗: 48 hours after dosing
Pharmacokinetic parameter of TPN171H:Cmax
Pharmacokinetic parameter of TPN171H:MRT
时间窗: 48 hours after dosing
Pharmacokinetic parameter of TPN171H:MRT
Pharmacokinetic parameter of TPN171H:AUC0-∞
时间窗: 48 hours after dosing
Pharmacokinetic parameter of TPN171H:AUC0-∞
Pharmacokinetic parameter of TPN171H:AUC0-24h
时间窗: 48 hours after dosing
Pharmacokinetic parameter of TPN171H:AUC0-24h
Pharmacokinetic parameter of TPN171H:CL/F
时间窗: 48 hours after dosing
Pharmacokinetic parameter of TPN171H:CL/F
次要结局
未报告次要终点