A Single-centre, Randomized, Open-label, Three-period Crossover Pharmacokinetic Study of 80 mg Telmisartan / 5 mg Amlodipine Fixed Dose Combination Compared With Its Monocomponents in Healthy Chinese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Cmax of Amlodipine
研究概览
简要总结
To determine the pharmacokinetic profile of 80 mg telmisartan / 5 mg amlodipine (T80/A5) dose combination after single dose in healthy Chinese subjects.
To determine whether a pharmacokinetic interaction exists between telmisartan and amlodipine, following single doses of 80mg telmisartan (T80), and 5 mg amlodipine (A5) tablet alone and in combination, in healthy Chinese subjects.
To evaluate the safety and tolerability of T80 and A5 alone and in combination in healthy Chinese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
amlodipine/telmisartan/combination
all patients will be assigned to 6 treatment sequences. cross-over design was adopted to ensure each patient would take amlodipine/telmisartan/combination single dose in randomized order
干预措施: amlodipine/telmisartan/combination (Drug)
结局指标
主要结局
Cmax of Amlodipine
时间窗: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days of wash-outs
Area Under the Concentration-time Curve of Telmisartan in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC_0-tz)
时间窗: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Area Under the Plasma Concentration-time Curve From the Time of Dosing to Infinity (AUC_0-∞) of Telmisartan
时间窗: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
AUC_0-∞ of Amlodipine
时间窗: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
The Maximum Observed Plasma Concentration (Cmax) of Telmisartan
时间窗: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
AUC_0-tz of Amlodipine
时间窗: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
次要结局
- Time to Attain Cmax (Tmax) of Telmisartan(3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs)
- Terminal Rate Constant in Plasma (λz) of Telmisartan(3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs)
- Elimination Half-life (t_½) of Telmisartan(3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs)
- MRT_po of Amlodipine(3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs)
- Number of Participants With at Least One Treatment Emergent Adverse Event(4 weeks)
- Number of Participants With Clinically Relevant Findings in Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities(4 weeks)
- Mean Residence Time of Telmisartan in the Body After Oral Administration (MRT_po)(3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs)
- Apparent Clearance of Telmisartan in Plasma Following Extravascular Administration (CL/F)(3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs)
- Apparent Volume of Distribution During the Terminal Phase λz Following an Extravascular Administration (V_z/F) of Telmisartan(3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs)
- Tmax of Amlodipine(3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs)
- λz of Amlodipine(3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs)
- V_z/F of Amlodipine(3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs)
- CL/F of Amlodipine(3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs)
- t_½ of Amlodipine(3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs)