A Randomized,Open-label,Single Dose,Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YH22162 in Comparison to the Co-administration of Twynsta and Hygroton in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Bioequivalence study is based on Cmax and AUC parameters
研究概览
简要总结
This is a Randomized, open-label, single-dose, 2-treatment, 2-period, 2-sequence crossover design.
详细描述
This is a 2 by 2 cross-over study to evaluate pharmacokinetics of YH22162 FDC compared to reference twynsta and Hygroton co-administered in two groups enrolling healthy adult male subjects under fasting conditions.
Subjects will be admitted to the clinic in the evening before Day 1. All subjects will receive a single oral dose of YH22162 FDC or twynsta and Hygroton co-administered in the morning on Day 1. All the subjects will remain in the clinical unit until completion of all assessments on Day 2 including collection post-dose PK sample. Subjects will return to the clinic for pharmacokinetic samples at scheduled time. The two treatment periods will be separated by a washout period.
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
- 19 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female with a body mass index(BMI) between 18.5 and 25 kg/m2
- •Who has not suffered from clinically significant disease
- •Provision of signed written informed consent
排除标准
- •History of and clinically significant disease
- •A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.
- •Administration of other investigational products within 3 months prior to the first dosing.
- •Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.
- •Sitting blood pressure meeting the following criteria at screening: 150 ≥ systolic blood pressure ≤100 (mmHg) and 100 ≥ diastolic blood pressure ≤ 60 (mmHg)
研究组 & 干预措施
Group 1 - Period 2
YH22162 FDC tablet of Yuhan Corporation
干预措施: YH22162 (Drug)
Group 1 - Period 1
Telmisartan/Amlodipine 80/5 mg (FDC) and Chlorthalidone 25mg
干预措施: Telmisartan/Amlodipine 80/5 mg (FDC) (Drug)
Group 1 - Period 1
Telmisartan/Amlodipine 80/5 mg (FDC) and Chlorthalidone 25mg
干预措施: Chlorthalidone 25mg (Drug)
Group 2 - Period 1
YH22162 FDC tablet of Yuhan Corporation
干预措施: YH22162 (Drug)
Group 2 - Period 2
Telmisartan/Amlodipine 80/5 mg (FDC) and Chlorthalidone 25mg
干预措施: Telmisartan/Amlodipine 80/5 mg (FDC) (Drug)
Group 2 - Period 2
Telmisartan/Amlodipine 80/5 mg (FDC) and Chlorthalidone 25mg
干预措施: Chlorthalidone 25mg (Drug)
结局指标
主要结局
Bioequivalence study is based on Cmax and AUC parameters
时间窗: 1 month
次要结局
未报告次要终点