KCT0001186进行中（未招募）未知
An open-label, randomized, multiple-dose crossover study to evaluate the pharmacokinetic drug-drug interaction of telmisartan/amlodipine 80/10mg and rosuvastatin 20mg in healthy male volunteers
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 55(Year)（—）
- 性别
- Male
入选标准
- •1) Healthy male korean subject age 19 to 55 at the screening visit.
- •2) As a result of measuring BMI, subject who is over 19 kg/m2, under 27 kg/m2 at the screening visit.
- •3) Before participating in this clinical study, subject who listened to explanation about the objective, contents of this study and characteristic of investigational product and volunteerly agreed in writing to participate in this study.
- •4) Subjcet who has ability and will to participate in this study.
排除标准
- •1) Subject who has history or presence of clinically significant disease in liver, kidney, digestive organ system, respiratory system, musculoskeletal system, endocrine system, nervous system, blood tumor, cardiovascular, etc.
- •2) Subject who has under 90mmHg or over 140mmHg of synizesis pressure or under 70mmHg or over 100mmHg of diastolic pressure in vital sign.
- •3) Subject who is hypersensitive to medicine containing component of amlodipine, telmisartan, rosuvastatin or other medicine(asprin, antibiotics, etc.).
- •4) Subject who has medical history of use of drugs of abuse and/or tested positive findings on urinary drug screening.
- •5) Subject who administers investigational product of other clinical study within 60 days before the first administration.
- •6) Subject who donated whole blood within recent 60 days or donated components of blood within recent 30 days before initiation of this study.
- •7) Subject who takes drug which can influence absorption, distribution, metabolism, elimination of amlodipine, telmisartan, rosuvastatin (gemfibrozil, cyclosporin, lopinavir/ritonavir, ketoconazole, rifampicin etc.) within 30 days before the first administration of the drug.
- •8) Subject who intakes alcohol above average 140 g/weeks or can't stop drinking during the treatment period.
- •9) Subject who smokes above average 10 cigarettes/day or can't stop smoking during the treatment period.
- •10) Subject who takes grapefruit/orange containing food and drink within 3 days before the first administration of the drug or can't stop taking during the treatment period.
- •11) As a result of serum test(tests for hepatitis B, hepatitis C, HIV), subject who tested positive.
- •12) numerical value of hepatic enzyme (Aspartate Transaminase, Alanine Transaminase) is over 1.5 times of the upper limit of reference range at the screening visit.
- •13) numerical value of Creatine Kinase is over 2 times of the upper limit of reference range at the screening visit.
- •14) numerical value of Estimated Glomerular Filtration Rate is under the lowest limit of reference range.
- •15) As a result of other laboratory examination results, Subject who has clinically significant abnormal.
- •16) As a result of ECG test, Subject who has clinically significant abnormal.
- •17) Subject who has hereditary myopathy or family history or medical history about myopathy, Myopathie caused by the drug.
- •18) Subject who estimated as an unsuitable subject for this study caused by other reason by investigator.
研究者
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