A Randomized, Open Label, Single Dose, 2-sequence, 4-period, Cross-over Phase I Clinical Trial to Compare and Evaluate the Safety and PK After Oral Administration of "LodienT Tablet 80/2.5mg" and "TWYNSTA Tablet 80/5mg" in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- AUCt
研究概览
简要总结
A randomized, open label, single dose, 2-sequence, 4-period, cross-over phase I clinical trial to compare and evaluate the safety and pharmacokinetics after oral administration of "LodienT tablet 80/2.5mg(telmisartan/s-amlodipine)" and "TWINSTA tablet 80/5mg(telmisartan/amlodipine)" in healthy adult volunteers.
详细描述
Amlodipine is a drug which belongs to calcium channel blockers (CCBs) and is used to treat hypertension. The molecule contains one chiral carbon atom and exists as a racemic mixture. As only the S-enantiomer of amlodipine [S-amlodipine] shows the CCB effect and R-amlodipine is responsible for the development of peripheral edema, purifying S-amlodipine can reduce the incidences of peripheral edema and other side effects.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers aged more than 19 years old
- •Subject does not have congenital or chronic disease and is without pathologic symptom or finding on medical exam.
- •Subject was determined eligible according to the results of clinical laboratory tests like serum test, hematologic test, blood chemistry test, urine test etc. and vital signs, electrocardiography, physical exam etc. performed during the screening exam.
- •90mmHg≤SBP≤139mmHg and 60mmHg≤DBP≤89mmHg)
- •Body mass index (BMI) of 18-30kg/m2
- •Willing and able to provide written informed consent
排除标准
- •Administration of other drug than can modulate metabolic enzyme within 1 months prior to the scrrening day.
- •Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs
- •Continued excessive use of alcohol(alcohol>21 cups/day) and severe heavy smoker (cigarette > 20 cigarettes per day)
- •Administration of other investigational products within 6 months prior to the first dosing
- •Subject with the following conditions in laboratory test : AST(sGOT) or ALT(sGPT) > Upper normal limit × 1.5
- •Subject with whole blood donation within 60 days, component blood donation within 14 days, blood donation within 30 days
- •Subject who take a medication that affect to the pharmacokinetics of drug within 10 days
- •Subject with decision of non-participation through investigator's review
研究组 & 干预措施
Reference
TWYNSTA Tablet 80/5mg(Telmisartan/Amlodipine)
干预措施: Twynsta (Drug)
Test
LodienT Tablet 80/2.5mg(Telmisartan/S-amlodipine)
干预措施: LodineT (Drug)
结局指标
主要结局
AUCt
时间窗: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48 and 72hr
Cmax
时间窗: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48 and 72hr
次要结局
未报告次要终点