Clinical study of phase 1 to evaluate the pharmacokinetic drug-drug interaction of hypertension medicine and hyperlipidemia medicine
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0001186
- Lead Sponsor
- Ildong pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Male
- Target Recruitment
- 48
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.
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax,ss, AUCt of Telmisartan;Cmax,ss, AUCt of Amlodipine;Cmax,ss, AUCt of Rosuvastatin
- Secondary Outcome Measures
Name Time Method tmax,ss, t1/2, Cmin,ss, Vd/Fss, CL/Fss of Telmisartan, Amlodipine and Rosuvastatin