NCT07166887已完成1 期
Pharmacokinetics, Pharmacological Effects and Safety of Multi Dose of 7.5mg Tolvaptan Tablet in Healthy Male Subjects
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Tolvaptan Pharmacokinetic
研究概览
简要总结
pharmacokinetics, pharmacological effects and safety of multi dose of 7.5mg Tolvaptan tablet in healthy male 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
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male, sign informed consent;
- •When signing the informed consent, the age range is 18-40 years old (including the upper and lower limits);
- •The body weight is not less than 50kg, and the body mass index is in the range of 19 ~ 24 (including the upper and lower limits);
- •According to the results of medical history, serological examination (HIV antibody, HBsAg, HCV antibody and syphilis antibody), physical examination, vital signs (temperature, blood pressure, pulse), 12-lead electrocardiogram, laboratory examination (blood routine, blood biochemistry, coagulation function and urine routine), etc., the subjects are certified as healthy.
排除标准
- •Patients with a history of heart, liver, kidney, digestive tract, metabolic, respiratory, blood, mental, nervous system and other disorders, and doctors judge that they are not suitable.
- •Patients with a history of various types of arrhythmias judged by the researchers to have clinical significance, including a history of familial genetic disease (a history of arrhythmias with a genetic tendency in relatives), and a history of rapid and slow arrhythmias, such as atrioventricular transmission Conduction block, sinus arrest, supraventricular tachycardia and so on.
- •Have a history, allergy or tendency to drugs and any other substances.
- •Known intolerance to components of the test drug, including lactose. For example, people with rare genetic galactose intolerance, lactase deficiency, or glucose-galactose malabsorption.
- •Various voiding disorders (frequent urination, or difficulty urinating, etc.).
- •People who smoke, drink or depend on other drugs.
- •Blood donors had an equivalent amount of blood loss (>350 ml) during the 12 weeks prior to enrollment.
- •Participated in any drug trials within 12 weeks prior to enrollment.
- •People who have taken preventive or therapeutic drugs in the last 2 weeks.
- •Consumed grapefruit or foods containing grapefruit in the week prior to administration.
- •In the investigator's judgment, the subject's diet deviates significantly from the normal intake of protein, carbohydrates, and fats (for example, vegetarian or vegan).
- •Have a history of postural hypotension (refers to a blood pressure drop of ≥20/10mmHg when the blood pressure changes from the lying position to the standing position, accompanied by dizziness and other symptoms), standing vertigo, collapse, syncopation, and vertigo.
- •Quiet for more than 3 minutes, sitting resting pulse below 55 beats/min or more than 90 beats/min.
- •Quiet for more than 3 minutes, sitting systolic blood pressure is lower than 100mmHg or higher than 140mmHg; Or diastolic depression of 60mmHg or more than 90mmHg.
- •Clinically significant 12-lead electrocardiogram abnormalities.
- •Clinically significant abnormalities in physical examination.
- •Positive for any of the serological tests for HIV antibodies, HBsAg, HCV antibodies and syphilis antibodies.
- •Other circumstances that the investigator determines may affect the subject's completion of the test.
研究组 & 干预措施
7.5mg Tolvaptan multi dosing group
Experimental
干预措施: Tolvaptan (Drug)
结局指标
主要结局
Tolvaptan Pharmacokinetic
时间窗: On Day 1: 0.5 hour before the first dose - the Day 9th pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, day 24 (only on Day 2 and Day 10th morning), 36 ( on Day 2 and Day 10th everning) and 48 hours - Day 4th to 8th day pre-dose
apparent volume of distribution (Vd/F)
次要结局
未报告次要终点
研究者
相似试验
已完成
1 期
Single Dose of 7.5mg Tolvaptan Phase I Clinical Trial ProtocolNCT07166783Otsuka Beijing Research Institute10
已完成
不适用
Efficacy and safety of administration of Tolvaptan twice daily in hospitalized acute heart failure patientsJPRN-UMIN000021110Japanese Red Cross Nagoya First Hospital50
已完成
2 期
Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKDAutosomal Dominant Polycystic Kidney DiseaseNCT01210560Otsuka Pharmaceutical Development & Commercialization, Inc.25
已完成
1 期
Pharmacokinetics/Pharmacodynamics (PK/PD) Characteristics of Tolvaptan Tablet in Korean Healthy MaleHealthyNCT01014416Korea Otsuka Pharmaceutical Co., Ltd.46
终止
不适用
Pharmacokinetics and Clinical Response of Tolvaptan in Neurocritical Care PatientsBrain InjuryHyponatremiaNCT02215148University of North Carolina, Chapel Hill1