None listed
Conditions
Interventions
Drug : [period 1]
part A : EXPO G Tab. (Amlodipine besylate/Valsartan, 10/160mg) 1 Tablet, administered once daily for 10 days
part B : Crestor Tab. (Rosuvastatin, 20 mg) 1 Tablet, administered once
Sponsors
Kyung Dong Pharmaceutical
Eligibility
Sex/Gender
Male
Inclusion 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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [part A] : Css,max, AUCt;[part B] : Css,max, AUCt | — |
Secondary
| Measure | Time frame |
|---|---|
| [part A] : AUCinf, Tss,max, t1/2;[part B] : AUCinf, Tss,max, t1/2 | — |
Countries
Korea, Republic of
Contacts
Public ContactJun Woo
Kyungpook National University Hospital
Outcome results
None listed