KCT0001660
Recruiting
未知
A phase I study to evaluate the pharmacokinetic interactions and safety between Amlodipine/Valsartan combination tablet and Rosuvastatin in healthy adult volunteers
Kyung Dong Pharmaceutical0 sites57 target enrollmentTBD
ConditionsDiseases of the circulatory system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the circulatory system
- Sponsor
- Kyung Dong Pharmaceutical
- Enrollment
- 57
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Healthy male subject‘s age \= 19 years at screening
- •2\) Body weight of \= 50 kg and within ± 20% of ideal body weight
- •? IBW (kg) \= height (cm) \- 100} \* 0\.9
- •3\) No abnormal symptom or sign, based on medical history and physical examination, with no congenital or chronic disease
- •4\) Subject that is considered eligible for participating in the study by an investigator, based on clinical laboratory test (serology, hematology, clinical chemistry, urinalysis, etc.) and ECG, performed within 3 weeks prior to administration of study drug
- •5\) Subjects who understand a detailed explanation of the study protocol, voluntarily decide to participate and follow the study instructions, and sign Informed Consent
Exclusion Criteria
- •1\) Medical History of clinically significant hypersensitivity to study drug (major ingredient or any other ingredient), any other drug or additives
- •2\) Medical history that may affect the absorption, distribution, metabolism or excretion (hepatobiliary, renal, cardiovascular, endocrine (e.g., hypothyroidism), respiratory, gastrointestinal, hemato\-oncology, central nervous system, psychiatric and musculoskeletal system)
- •3\) an history (or family history) of muscle disease hereditarily
- •4\) Hypotension (systolic \= 115 mmHg or diastolic \= 65 mmHg) or hypertension (systolic \= 150 mmHg or diastolic \= 100 mmHg), measured at screening
- •5\) Active liver disease, or the levels of ALT, AST or total bilirubin \> 1\.5 x the upper limit of normal
- •6\) Creatinine clearance \< 80 mL/min (calculated by Cockcroft\-Gault formula using serum creatinine)
- •7\) History of gastrointestinal disease (e.g., Crohn’s disease, active peptic ulcer) or gastrointestinal surgery that may affect the absorption of the study drug (excluding simple appendectomy or herniorrhaphy)
- •8\) History of major injury, surgical operation, or suspected symptom of acute illness (severe infection, trauma, diarrhea or vomiting, etc.) within 4 weeks prior to the first administration of study drug
- •9\) History of excessive alcohol abuse (\>21 units/week, 1 unit\=10g\=12\.5mL of pure alcohol), or subjects who cannot abstain from drinking for at least 3 days prior to the start of this study and during the study period, or excessive smoking (\>10 cigarettes/day)
- •10\) Use of any prescribed drugs or herbal remedies within 2 weeks, or use of any over\-the\-counter medication within 1 week prior to the first administration of study drug, and this will affect this study or the safety of the subjects in the opinion of the investigator
Outcomes
Primary Outcomes
Not specified
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