A phase I study to evaluate the pharmacokinetic interactions and safety between Amlodipine/Valsartan combination tablet and Rosuvastatin in healthy adult volunteers
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0001660
- Lead Sponsor
- Kyung Dong Pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 57
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
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
11) Participation in any other study within 3 months prior to the first administration of study drug (The completion date of previous study is the day of the last administration of study drug)
12) Donation of whole blood within 2 months prior to the first administration of study drug, or donation of any blood component within 1 month prior to the first administration of study drug
13) Abnormal diet that may affect absorption, distribution, metabolism and excretion of drugs (*e.g., Grapefruit juice = 1L /day within 7 days prior to administration of study drug)
14) Positive serologic tests (HBsAg, HCV Ab, HIV Ag/Ab, VDRL)
15) Subject that is not eligible to participate at the discretion of study investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method [part A] : Css,max, AUCt;[part B] : Css,max, AUCt
- Secondary Outcome Measures
Name Time Method [part A] : AUCinf, Tss,max, t1/2;[part B] : AUCinf, Tss,max, t1/2