NCT03889145已完成1 期
A Randomized, Open-label, Single Dose, 3-way Crossover Study to Evaluate the Drug-drugs Interaction Between 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
- 30
- 主要终点
- AUClast
研究概览
简要总结
A randomized, open-label, single dose, 3-way crossover study to evaluate the drug-drugs interaction between 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
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers aged 20 to 55 years
- •Subjects who have 17.5 ~ 30.5 kg/m2 body mass index (BMI) and body weight that is more than 55kg
- •Subjects who have no congenital or chronic disease within the last 3 years and have no pathological symptoms or findings as a result of medical examination.
- •Suitable subject who is determined by laboratory tests such as hematology tests, blood chemistry, urinalysis test according to the characteristics of the drug and screening tests such as electrocardiography(ECG) test.
- •Subject who fully understand the clinical trials after in-depth explanation given prior to the clinical study, decided to join the clinical trials by their will and signed consent form which approved by Chonbuk National University Hospital Institutional Review Board(IRB).
排除标准
- •Subjects who have a history of blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic diseases that is clinically significant (Except untreated asymptomatic seasonal allergies at the time of administration)
- •Subjects who have a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption.
- •Subjects who drink Alcohol > 210g/week within 6 months prior to the screening.
- •Subjects who involved in other clinical trials within two months before the first dose medication characters.
- •Subjects who show Systolic Blood Pressure ≤100 or ≥150 mmHg or Diastolic Blood Pressure ≤60 or ≥100 mmHg at screening
- •Subjects who had alcohol or drug abuse within one year before the screening
- •Subjects who took medication of drug-metabolizing enzymes that are known to significantly induce or inhibit within 30 days
- •Subjects who smoke 20 cigarettes or more a day
- •Subjects who take medicine within 10 days before the first investigational product administration.
- •Subject who done the whole blood donation within two months or component blood donation within 1 month within 1 month prior to the first dosing.
- •Subject 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.
- •Subjects with serious history of hypersensitivity or allergy to investigational product.
- •Subjects with severe hepatic impairment or Gallbladder Disease.
- •Subject with hereditary angioedema or a history of angioedema when treated with ACE(Angiotensin-Converting enzyme) inhibitor or ARB(Angiotensin II Receptor Blocker) therapy
- •Subjects who take combination medication with aliskiren in Diabetic patient or moderate to severe renal insufficient subjects (glomerular filtration rate<60mL/min/1.73m2)
- •Subjects with severe hepatic impairment
- •Subjects who have severe aortic stenosis
- •Subjects with acute or severe renal failure
- •Subjects with hyponatremia or hypokalemia
- •Subjects with Addison's disease
- •Subjects with hypercalcemia
- •Subjects who have galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •Subjects who are unwilling or unable to comply with the Lifestyle guidelines described in this protocol
- •Subject who are inadequate for this study to participate judged by investigator
研究组 & 干预措施
Telmisartan, Amlodipine, Hydrochlorothiazide
Experimental
干预措施: Hydrochlorothiazide (Drug)
Telmisartan, Amlodipine
Active Comparator
干预措施: Telmisartan 80mg (Drug)
Telmisartan, Amlodipine
Active Comparator
干预措施: Amlodipine10mg (Drug)
Hydrochlorothiazide
Active Comparator
干预措施: Hydrochlorothiazide (Drug)
Telmisartan, Amlodipine, Hydrochlorothiazide
Experimental
干预措施: Telmisartan 80mg (Drug)
Telmisartan, Amlodipine, Hydrochlorothiazide
Experimental
干预措施: Amlodipine10mg (Drug)
结局指标
主要结局
AUClast
时间窗: 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, 120, 144(Total 19 points)]
Cmax
时间窗: 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, 120, 144(Total 19 points)]
次要结局
- Tmax(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, 120, 144(Total 19 points)])
- AUCinf(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, 120, 144(Total 19 points)])
研究者
相似试验
已完成
1 期
Teneligliptin and Atorvastatin DDI StudyDiabete MellitusNCT03769870Handok Inc.30
已完成
1 期
Food and Relative Bioavailability StudyDepressive DisorderNCT00843011GlaxoSmithKline14
已完成
1 期
Relative Bioavailability and Food Effect Study of CVN424Parkinson's DiseaseNCT05635461Cerevance Beta, Inc.32
已完成
1 期
Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD 371 in Healthy SubjectsType II Diabetes MellitusNCT05544214Chong Kun Dang Pharmaceutical32
已完成
1 期
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed)Cardiovascular DiseasesNCT04083846Chong Kun Dang Pharmaceutical24