Pharmacokinetic, Pharmacodynamic Profiles and Safety After Oral Administration of Ivabradine in Male Healthy Korean Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Cmax,tmax, AUC(Area under the time-concentration curve) of ivabradine and metabolite
研究概览
简要总结
- To assess the pharmacokinetic profile of ivabradine (S 16257) and its main active metabolite S 18982 in Korean healthy volunteers after oral administration of ivabradine at the doses of 2.5, 5, 10mg and after repeated oral administrations of ivabradine for 4.5 days at the same doses twice daily versus placebo and to use the study results for bridging with Caucasian data.
- The pharmacodynamic profile of ivabradine versus placebo by measuring its effects on heart rate after single and then after repeated administrations.
- Clinical safety of ivabradine versus placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- •age between 18 and 40 years and Korean
- •Nonsmoker or smoke less than 5 cigarettes per day
- •normal dietary habits
- •BMI ranging from 18 to 25 kg/m2
- •good physical and mental status, determined by the investigator
- •vital signs in resting condition within range: SBP 100-139 mmHg, DBP 50-89 mmHg
- •Normal ECG
排除标准
- •Participate any other trial in the last 3 months prior to the study
- •History of major psychiatric, medical, surgical disorders
- •Acute, or chronic disease
- •History of hypersensitivity to at least one drug
- •History of alcoholism or positive alcohol breath test
- •Positive drug screening results
- •known positive serology for HIV1, HIV2, hepatitis B or C
- •blood donor within the last 3 month of the study
- •regular use of sedatives, hypnotics, tranquillisers
研究组 & 干预措施
Ivabradine
Single and repeated oral administrations of 3 doses of ivabradine
干预措施: Ivabradine and placebo (Drug)
Placebo
Placebo administration
干预措施: Ivabradine and placebo (Drug)
结局指标
主要结局
Cmax,tmax, AUC(Area under the time-concentration curve) of ivabradine and metabolite
时间窗: within 60 days after blood sampling (blood sample analysis)
For PK measurements, blood samplings were done: pre-dose then 20 min, 40 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h, 60 h, and 72 h following the D1 single administration (P1) and the Day 8 (D8) last repeated dose (P2), respectively.Ivabradine and its main metabolite were determined using LC-MS/MS, then pharmacokinetic parameters were calculated by noncompartmental approach. Descriptive statistics were performed on the PK individual parameters calculated from the plasma concentration-time profiles.
次要结局
- pharmacodynamics: The change of heart rate between baseline and over 24-hour, diurnal, nocturnal, awake, and asleep periods after administration of ivabradine(within 10 days after administration)
研究者
Kyun-Seop Bae
Dep. of clinical pharmacology and therapeutics
Asan Medical Center