KCT0001186
Active, not recruiting
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
ConditionsDiseases of the circulatory system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the circulatory system
- Sponsor
- Ildong pharmaceutical
- Enrollment
- 48
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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