jRCT2080221540未知1 期
Pharmacokinetic study of olmesartan medoxomil/amlodipine 20/5 mg tablet in Chinese healthy adult volunteers
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 主要终点
- Safety parameters
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Open-label, single-dose and multiple-dose clinical trial
入排标准
- 年龄范围
- 18age old over 至 45age old under（—）
- 性别
- All
入选标准
- •Inclusion criteria:
- •Healthy male or female;
- •Aged 18 to 45 years;
- •Body weight >= 50 kg, body mass index (BMI) [weight (kg) / height 2 (m2)] is between 19 and 24;
- •Healthy status was confirmed by medical history, comprehensive physical examination and laboratory tests;
- •Subjects signed informed consent form.
排除标准
- •Exclusion criteria:
- •Unable or unwilling to sign the informed consent form;
- •Clinically significant abnormalities was found after physical examination, or laboratory tests showed clinically significant abnormal values;
- •Any of the result of serological screening tests, including: HIV antibody, HBV (HBeAg, HBsAg), HCV antibody, TPPA, is positive;
- •Present with a history of cardiovascular, liver, kidney, gastrointestinal, or neurological/mental diseases;
- •With known hypersensitivity to the investigational drug or any ingredient of the investigational drug;
- •Having blood donation within the last 3 months;
- •Systolic blood pressure below 100 mmHg, and/or diastolic blood pressure below 50 mmHg at screening;
- •Pregnant or breast-feeding women, or women of childbearing potential who failed to take effective contraceptive measures;
- •With a history of alcohol dependence or drug abuse, and/or positive result in drug screening or alcohol breath test;
- •The subjects who required elective surgery during the study;
- •Subjects who had participated in drug clinical trial one month before study entry, or had plan to participate in other drug clinical trial during this study;
- •The subjects who received any medication two weeks before study entry (excluding daily dose of not more than 1 g paracetamol);
- •The subjects who smoke > 15 cigarettes/day during the 12 months before screening, and/or positive for tobacco screening test;
- •The ineligibility of subjects to participate in this study was evaluated by the investigator.
结局指标
主要结局
Safety parameters
The safety assessment in this study included adverse events, laboratory tests (blood routine tests, urinalysis, blood biochemistry), vital signs, physical examination, 12-lead ECG.
Pharmacokinetic parameters (single-dose)
时间窗: single-dose administration period
The following parameters were determined in single-dose administration period: C max (ng/ml), AUC(0 - t) (micro g.h/L), AUC(0 - infinity) (micro g.h / L), Tmax (h) , T1/2 (h), CL/F (L/h), CLr (L/h), V/F (L), Ke (h-1), the cumulative excretion rate (%), amount of excretion ( mg).
Pharmacokinetic parameters (multi-dose)
时间窗: multi-dose administration period
The following parameters were determined in multi-dose administration period: Cmax (ng/ml), Cav (ng/ml), Tmax (h), T1/2 (h), CL/F (L/h), V/F (L), Ke (h-1), DF (%), AUCss (0 - t) (micro g.h/L), AUCss (0 - infinity) (micro g.h/L), Ro.
次要结局
未报告次要终点
研究者
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