A Randomized, Blind, Placebo-controlled, Three-way Crossover Study Evaluating the Interaction of TPN171H Tablets and Alcohol in Healthy Chinese Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Maximum change in blood pressure (SBP and DBP)
研究概览
简要总结
The purpose of this study is primarily to evaluate the effects of taking TPN171H tablets with alcohol on blood pressure, pulse,and pharmacokinetic in Chinese healthy male subjects.
详细描述
This study will be divided into two parts: pre-test and formal test. The pre-trial is an open design to evaluate the safety and tolerability of TPN171H tablets in combination with alcohol in healthy male subjects. Two subjects at 5 mg and 10 mg doses will be taken with alcohol, blood pressure (SBP and DBP), pulse, alcohol breath monitoring and PK blood sample collection were required, and the time point was the same as the formal test.
The dosage of TPN171H tablets in the formal trial will be determined according to the preliminary test results.
The formal trial is a single-centre, blind, randomized, placebo-controlled, three-period, three-way crossover study, in which each subject will be randomized to receive each of the following three treatments with a washout period of at least 3 days between treatments:
Treatment A: a single oral dose of one10 mg or 5 mg TPN171H tablet plus an oral dose of alcohol drink mixed with fruit juice (0.5 g of absolute ethanol per kilogram of body weight).
Treatment B: a single oral dose of one placebo tablet plus an oral dose of alcohol drink mixed with fruit juice (0.5 g of absolute ethanol per kilogram of body weight).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Voluntarily sign and abide by the contents of the informed consent;
- •Adult male subjects, either 21 to 45 years of age,
- •Body weight ≥55 kg; Body mass index (BMI) in the range of 19.0-26.0 kg/m2 (including the critical value);
- •Subjects must agree to use at least one method of birth control for at least three months from the time of the first dose to at least the last;
- •Normal or abnormal important indicators of physical examination, vital signs examination, electrocardiogram examination and laboratory examination have no clinical significance as judged by the researcher.
排除标准
- •Unable to consume alcohol according to 0.5 g/kg (body weight);
- •After ingestion of 0.5 g/kg alcohol, the instrument showed alcohol concentration ≥120 mg/100 mL after exhalation, or moderate or severe acute alcoholism, which was judged by the investigator to be unfit to continue to participate in the study (see Appendix 1 for clinical classification of acute alcoholism);
- •Systolic pressure in decubitus (semi-decubitus) position < 90 or ≥140 mmHg; Diastolic pressure in decubitus (semi-decubitus) position < 60 or ≥90 mmHg；
- •Known allergic history, patients with allergic diseases or allergic predisposition to the study product or any of its components or related product;
- •May significantly affect drug absorption, distribution, metabolism and excretion of any surgical situation or condition, or may pose a hazard to participate in research subjects of any surgical situation or condition, such as the history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), gastroenteritis, gastrointestinal ulcers, gastrointestinal bleeding history etc. (except for gallbladder removal);
- •Patients with myocardial infarction, severe/unstable angina pectoris, coronary artery/peripheral artery bypass graft, congestive heart failure, severe arrhythmias, and cerebrovascular accidents, including transient ischemic attack, within 6 months prior to the administration of the study drug;
- •Those who had used any drugs to inhibit or induce drug metabolism in the liver within 4 weeks before enrollment or needed to use any drugs in combination during the study period; Patients taking nitrates in any form;
- •Known history of the following eye diseases: non-avascular ischemic optic neuropathy (NAION), abnormal color vision, hereditary retinal degeneration (e.g. Retinitis pigmentosa), macular degeneration;
- •Known history of sudden hearing loss or loss;
- •A history of postural hypotension;
- •Patients with blood loss >400 mL within 3 months before inclusion;
- •Participated in clinical research of other drugs or medical devices within 3 months prior to inclusion;
- •Current or previous alcoholics (drinking more than 14 standard units per week. 1 standard unit containing 14 g alcohol, such as 360 mL beer or 45 mL 40% spirits or 150 mL wine), or positive breath test for alcohol;
- •Have a history of drug use or have been screened positive for drug abuse;
- •Smokers who smoked more than 10 cigarettes a day within 6 months prior to inclusion;
- •Human immunodeficiency virus antibody (HIV), hepatitis C virus antibody (anti-HCV), hepatitis B surface antigen (HBsAg), treponema pallidum antibody (anti-TP) positive;
- •Alcohol sensitivity test positive;
- •There were other factors that the investigator considered inappropriate for the study.
研究组 & 干预措施
alcohol plus TPN171H
0.5 g/Kg alcohol plus 10 mg TPN171H tablet
干预措施: TPN171H tablet plus alcohol (Drug)
alcohol
0.5 g/kg alcohol
干预措施: alcohol (Other)
TPN171H
10 mg TPN171H tablet
干预措施: TPN171H tablet (Drug)
结局指标
主要结局
Maximum change in blood pressure (SBP and DBP)
时间窗: 48 hours after treatment
Maximum change in decubitus (semi-decubitus) blood pressure (SBP and DBP) from baseline
The area under effect-time curve (AUEC0- 4h) of supine systolic (SBP) and diastolic (DBP) blood pressure, and pulse
时间窗: 4 hours after treatment
The area under effect-time curve (AUEC0- 4h) of supine systolic (SBP) and diastolic (DBP) blood pressure, and pulse relative to baseline change.
Maximum change in pulse
时间窗: 48 hours after treatment
Maximum change from baseline in decubitus (semi-decubitus) position;
次要结局
未报告次要终点