NCT03032315已完成1 期
Clinical Trial to Compare the Pharmacokinetics of TAH Tablet(80/10/12.5mg) in Comparison to the Co-administration of Telmisartan, Amlodipine and Hydrochlorothiazide in Healthy Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
randomized, open-label, single dose, replicate crossover clinical trial to compare the pharmacokinetics of TAH(80/10/12.5) tablet in comparison to the co-administration of telmisartan, amlodipine and hydrochlorothiazide in healthy male volunteers
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers aged 19 to 55 years
- •body mass index (BMI) of 17.5-30.5kg/m2 and weigh more than 55kg
- •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. 5) willing and able to provide written informed consent
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
- •A subject with a history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug
- •History of regular alcohol consumption (> 210 g/week) within the 6 months before the screening visit.
- •Subjects who take the medication involved in other clinical trials or bioequivalence tests within three months before the first dose medication characters.
- •Seated systolic blood pressure <100mmHg or ≥ 150 mmHg , or diastolic blood pressure of <600mmHg or ≥ 100mmHg at the screening visit
- •History of alcohol or drug abuse within the 12 months before the screening visit
- •Subjects who treated with metabolizing enzyme inducers or inhibitors such as barbitals within 30days prior to the first dosing.
- •Smoker who smoke more than 20 cigarettes per day
- •Subjects who take ethical the count or over the count medicine within 10days before the first investigational product administration.
- •Blood Subjects who do the whole blood donation within two months or component blood donation within 1month prior to the first dosing.
- •Subjects who can increase risk due to clinical test and administration of drugs or has Severe grade / chronic medical, mental condition or abnormal laboratory result that may interfere with the analysis of test results.
- •Subject with known for hypersensitivity reaction to TWYNSTA TAB or dihydropyridine derivatives
- •Subject with known for hypersensitivity reaction to thiazide diuretics or Sulfonamides
- •Patients with biliary obstructive disorder
- •Patients receiving other drugs that affect RAAS such as Angiotensin Receptor Blocker(ARB), ACE inhibitors or aliskiren
- •Combination with aliskiren in Diabetic patient or moderate to severe renal insufficient subjects (glomerular filtration rate<60mL/min/1.73m2)
- •Patients with severe hepatic impairment
- •Patients with severe aortic stenosis
- •Patients with history of shock
- •Patients with anuria
- •Patients with acute or severe renal failure
- •Patients with hyponatraemia hypokalemia
- •Patients with Addison's disease
- •Patients with hypercalcemia of malignancy
- •Who has Galactose intolerance, LAPP lactose intolerance, glucose-galactose malabsorption or genetic disorders
- •Test subjects who is not willing or unable to comply with guidelines described in this protocol
- •A person who is not determined unsuitable to participate in this test by the researchers
研究组 & 干预措施
TAH(80/10/12.5) tablet
Experimental
Telmisartan/Amlodipine besylate/Hydrochlorothiazide(80/10/12.5) tablet
干预措施: TAH Tablet (Telmisartan80/Amlodipine besylate10/Hydrochlorothiazide12.5) (Drug)
Telmisartan+Amlodipine besylate+Hydrochlorothiazide
Active Comparator
coadministration of Telmisartan, Amlodipine besylate and Hydrochlorothiazide
干预措施: TWYNSTA(Telmisartan+Amlodipine besylate) (Drug)
Telmisartan+Amlodipine besylate+Hydrochlorothiazide
Active Comparator
coadministration of Telmisartan, Amlodipine besylate and Hydrochlorothiazide
干预措施: Hydrochlorothiazide (Drug)
结局指标
主要结局
Cmax
时间窗: [Time Frame: Hour 0 (Pre-dose), Hour 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144 (Total 18 points)]
AUClast
时间窗: [Time Frame: Hour 0 (Pre-dose), Hour 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144(Total 18 points)]
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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