Tolvaptan Oral Administration Phase I Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 主要终点
- single dose Tolvaptan plasma pharmacokinetics, and its motablics DM-4103 and DM-4107
研究概览
简要总结
Tolvaptan oral administraction phase I PK clinical trial. Two groups of healthy male subjects. One group receives single dose of Tolvaptan. The other group receives multi dose of Tolvaptan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Healthy male volunteers.
- •Aged 18 to 40 years old.
- •Weight no less than 50kg and within the range of standard weight (body mass index between 19 and 24).
- •Auxiliary examinations: blood routine and coagulation, urine routine, blood biochemistry (total protein, albumin, blood glucose, total bilirubin, AST (GOT), ALT (GPT), ALP, γ-GTP, LDH, CK (CPK), total cholesterol, triglycerides, urea nitrogen, creatinine, uric acid, Na, K, Cl, Mg, Ca, P), hepatitis B surface antigen, hepatitis C antibody, HIV antibody, syphilis antibody, 12-lead electrocardiogram, 24-hour ambulatory electrocardiogram (Holter) examination, all items are normal.
- •Signed the informed consent form.
排除标准
- •The patient has a history of heart, liver, kidney, digestive tract, metabolic, respiratory, blood, mental, nervous system and other disorders, and the doctor's judgment is not suitable.
- •Hepatitis B virus, syphilis, hepatitis C virus, HIV infection.
- •Patients with a history of clinically significant arrhythmias of various types, including rapid and slow types, such as atrioventricular block, sinus arrest, and supraventricular tachycardia, were assessed by the investigators.
- •He has a history of postural hypotension (blood pressure drop ≥20/10mmHg when he changes from lying position to standing position, accompanied by dizziness and other symptoms), standing dizziness, collapse, fainting, and vertigo.
- •Quiet for more than 3 minutes, sitting 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; Diastolic depression of 60mmHg or higher than 90mmHg.
- •Various voiding disorders (frequent urination, or difficulty urinating, etc.).
- •Have a family history of genetic diseases (including a history of genetically predisposed arrhythmias in relatives).
- •A history, allergy or propensity to be allergic to drugs or any other substance.
- •Smokers, alcoholics, or other drug addicts.
- •Physical examination had clinically significant positive findings.
- •People who have donated blood or been sampled as a subject within the last 3 months.
- •People who have taken prophylactic or therapeutic drugs in the last 2 weeks.
- •Otherwise, the clinical trial physician or the clinical trial physician determines that the safety of the trial is affected.
研究组 & 干预措施
single dose
干预措施: singe dose 15mg (Drug)
single dose
干预措施: single dose 30mg (Drug)
single dose
干预措施: single dose 60mg (Drug)
single dose
干预措施: single dose 120mg (Drug)
multi dose
干预措施: multi dose 30mg (Drug)
multi dose
干预措施: multi dose 60mg (Drug)
结局指标
主要结局
single dose Tolvaptan plasma pharmacokinetics, and its motablics DM-4103 and DM-4107
时间窗: Day 1 pre-dose and post-dose 0.5 hour, 1 ,2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours
apparent volume of distribution (Vd/F)
multi dose Tolvaptan plasma pharmacokinetics and it's motablics DM-4107 and DM-4103
时间窗: Day 1 & Day 9 at pre-dose, post-dose 0.5hr, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 (2nd and 10th day) and 48 (day 3rd and 11th). For other dosing day ( day 4 to 8) to collect at pre-dose( 24hr after last dose) point
apparent volume of distribution (Vd/F)
Tolvaptan plasma pharmacokinetics, and its motablics DM-4103 and DM-4107
时间窗: Day 1 pre-dose and post-dose 0.5 hour, 1 ,2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours
area under the drug-time curve (AUC0-t and AUC0-∞)
次要结局
未报告次要终点