NCT01014416已完成1 期
A Dose Block-randomized, Double-blind, Placebo-controlled, Single Dose, Dose-escalation Study to Investigate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of Tolvaptan in Healthy Korean Male Subjects Bipolar Disorder
适应症
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
- 46
- 试验地点
- 1
- 主要终点
- PK parameters: AUC, Cmax, Tmax
研究概览
简要总结
To investigate the safety, tolerance, pharmacokinetics and pharmacodynamics of tolvaptan 15, 30 and 60 mg after single oral administration in healthy Korean male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Korean male subjects between 20 and 45 years of age, inclusive.
- •Body Mass Index (BMI) of 20 to 26 kg/m2, body,weight ≥ 50kg BMI = weight (kg)/height2(m)
- •Informed consent from the subjects
排除标准
- •Clinically significant abnormality of respiratory, cardiovascular, hepatic, neurologic, endocrine, hematologic, urinary, psychiatric.
- •History of gastrointestinal disease or surgery which can affect intestinal absorption of the study drug.
- •History of any significant drug allergy or hypersensitivity.
- •AST or ALT > 1.25 times upper normal limit at screening clinical laboratory test
- •Supine blood pressure after resting for ≥ 3 minutes, higher than 140/90 mmHg or lower than 100/50 mmHg, Supine pulse, after resting for ≥ 3 minutes, outside the range of 40 to 90 beats/minute.
- •Subjects who had history of drug abuse or alcohol addiction
- •Subjects who used of any prescription drug or herbal medication within 2 weeks prior to the first dosing of the study drug, or any over-the-counter or vitamin supplements within 1 week prior to the first dosing (However, investigators can judge the subject, who has taken the medications during those periods above, eligible for the trial if all other conditions are satisfied)
- •The investigator judges the subject not eligible for the study after reviewing clinical laboratory results or other reasons.
研究组 & 干预措施
Arm 1
Experimental
Single dose, Tolvaptan 15mg or Placebo/day
干预措施: Tolvaptan 15mg or 30mg or 60mg or Placebo (Drug)
Arm 3
Experimental
Single dose, Tolvaptan 60mg or Placebo/day
干预措施: Tolvaptan 15mg or 30mg or 60mg or Placebo (Drug)
Arm 2
Experimental
Single dose, Tolvaptan 30mg or Placebo/day
干预措施: Tolvaptan 15mg or 30mg or 60mg or Placebo (Drug)
结局指标
主要结局
PK parameters: AUC, Cmax, Tmax
时间窗: 1 day
PD parameters: 24 hour fluid balance
时间窗: 1 day
Safety: adverse event, body weight, physical examination, vital sign, ECG, clinical laboratory test
时间窗: 4 days
次要结局
未报告次要终点
研究者
研究点 (1)
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