Pharmacokinetic and Hemodynamic Interactions Between Amlodipine and Losartan in Humans
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state)
研究概览
简要总结
This clinical trial aims to assess the pharmacokinetic interaction between amlodipine and losartan 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
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers aged between ≥ 20 and ≤ 45 years old
- •Weight ≥ 50kg, with calculated body mass index(BMI) of ≥ 18 and ≤ 29.9kg/m²
- •Subjects who agree to use a combination of effective contraceptive methods or medically acceptable contraceptive methods for up to 28 days after the date of administration of the clinical trial drug and agree not to provide sperm
- •Subject who are informed of the investigational nature of this study, voluntarily agree to participate in this study
排除标准
- •History or presence of a clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic or psychiatric disorder
- •With symptoms indicating acute illness within 28 days prior to the first Investigational Product administration
- •Any medical history that may affect drug absorption, distribution, metabolism, and excretion
- •Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
- •Any clinically significant active chronic disease
研究组 & 干预措施
Amlodipine, losartan, and amlodipine plus losartan
Period 1:
amlodipine 10mg will be administered orally once a day for 9 days.
Period 2:
losartan 100mg will be administered orally once a day for 9 days after 13 days of the washout period.
Period 3:
amlodipine 10mg once a day plus losartan 100mg once a day will be administered orally for 9 days after 6 days of the washout period.
干预措施: Amlodipine10mg (Drug)
Amlodipine, losartan, and amlodipine plus losartan
Period 1:
amlodipine 10mg will be administered orally once a day for 9 days.
Period 2:
losartan 100mg will be administered orally once a day for 9 days after 13 days of the washout period.
Period 3:
amlodipine 10mg once a day plus losartan 100mg once a day will be administered orally for 9 days after 6 days of the washout period.
干预措施: Losartan potassium 100mg (Drug)
Amlodipine, losartan, and amlodipine plus losartan
Period 1:
amlodipine 10mg will be administered orally once a day for 9 days.
Period 2:
losartan 100mg will be administered orally once a day for 9 days after 13 days of the washout period.
Period 3:
amlodipine 10mg once a day plus losartan 100mg once a day will be administered orally for 9 days after 6 days of the washout period.
干预措施: Amlodipine plus Losartan (Drug)
结局指标
主要结局
AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state)
时间窗: 0 (predose) ~ 24 hours at day 9, day 31, and day 46
Cmax,ss(Maximum plasma concentration of the drug at steady state)
时间窗: 0 (predose) ~ 24 hours at day 9, day 31, and day 46
次要结局
- PTF(Peak-to-trough fluctuation)(0 (predose) ~ 24 hours at day 9, day 31, and day 46)
- Vd,ss/F(Apparent volume of distribution at steady state)(0 (predose) ~ 24 hours at day 9, day 31, and day 46)
- Tmax,ss(Time to maximum plasma concentration at steady state)(0 (predose) ~ 24 hours at day 9, day 31, and day 46)
- 1/2(Terminal elimination half-life)(0 (predose) ~ 24 hours at day 9, day 31, and day 46)
- Cmin,ss(Minimum concentration of the drug in plasma at steady state)(0 (predose) ~ 24 hours at day 9, day 31, and day 46)
- CLss/F(Apparent total body clearance of the drug from plasma at steady state)(0 (predose) ~ 24 hours at day 9, day 31, and day 46)
研究者
Ji-Young Park
Professor
Korea University Anam Hospital