A Randomized, Open Label, Multiple Dose, Crossover Study to Investigate Pharmacokinetic Drug Interactions Between Single and Concomitant Administrations of Amlodipine, Losartan, and Hydrochlorothiazide(HCTZ) in Subjects With (Pre)Hypertension
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
研究概览
简要总结
This study is aimed to evaluate the pharmacokinetics and the drug-drug interaction among anti-hypertension drugs-amlodipine, losartan, and hydrochlorothiazide. This pilot study provides useful information to develop a new fixed dose combination drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult subjects 20-50 years of age
- •Above 55Kg and within ±20% ideal body weight
- •Subjects who are in average of 130mmHg ≤ systolic blood pressure (SBP) < 160mmHg, 80mmHg ≤ diastolic blood pressure (DBP) < 100mmHg
- •Female subject who confirmed non-pregnant status and agree to comply with proper contraception.
- •Subjects who wrote informed consent
排除标准
- •Subjects who are suspected to have acute disease
- •Subjects who have past history that may affect drug absorption, distribution, metabolism and elimination
- •Subjects who have gastrointestinal history
- •Subjects whose heartrate is less than 60
- •Subject who suspected to orthostatic hypotension
- •Subjects who have clinically significant allergy disease
- •Subject is currently participating or has participating in a study with an investigational compound or device within 30 days of signing informed consent
- •Administration of prescription drug within 14 days or over the counter (OTC) drug within 7 days
- •Subjects who have past history of drug abuse and positive in drug screening test
- •Subjects who donate whole blood within 60 days and platelet within 30days.
- •Subjects taking St John's wort or CYP inhibitor and inducer
研究组 & 干预措施
amlodipine monotherapy
干预措施: multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide (Drug)
losartan monotherapy
干预措施: multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide (Drug)
HCTZ
干预措施: multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide (Drug)
mlodipine and Losartan and HCTZ
干预措施: multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide (Drug)