clinical trial to assess the pharmacokinetic characteristics of lodivixx tab. 5/160mg in healthy male subjects (n=27)

Conditions: Healthy Male Subjects

Summary: to assess the pharmacokinetic characteristics of valsartan and s-amlodipine after single oral administration of exforge tab. 10/160mg, a combination formulation of valsartan and amlodipine as reference drug and lodivixx tab. 5/160mg, a combination formulation of valsartan and s-amlodipine as test drug in healthy male adults

the purpose of this study is to assess the pharmacokinetic characteristics of valsartan and s-amlodipine after single oral administration of exforge tab. 10/160mg, a combination formulation of valsartan and amlodipine as reference drug and lodivixx tab. 5/160mg, a combination formulation of valsartan and s-amlodipine as test drug in healthy male adults. additionally the safety and tolerability of two drugs will be evaluated.

Eligibility criteria:
inclusion criteria: * years 20-45 * body weight ≥ 50kg and 18 ≤ bmi ≤ 29kg/m2 * volunteer for the study and sign to icf exclusion criteria: * subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease * subject with symptoms of acute disease within 28 days prior to study medication * subject with history which affect on the absorption, distribution, metabolism or excretion of drug * subject with clinically significant active chronic disease * subject with any of the following conditions in laboratory test i. ast(sgot) or alt(sgpt) \> upper normal limit × 1.5 ii. total bilirubin \> upper normal limit × 1.5 iii. renal failure with creatinine clearance \< 50ml/min * clinically significant hypotension when screening period (sbp \< 100mmhg, dbp \< 60mmhg) * positive test results for hbs ab, hcv ab, syphilis regain test * use of any prescription medication within 14 days prior to study medication * use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing * subject with clinically significant allergic disease (except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug) * subject with known for hypersensitivity reaction to s-amlodipine, amlodipine and valsartan and dihydropyridine derivatives * subject who is not able to taking the institutional standard meal * subjects with whole blood donation within 60 days, component blood donation within 20 days * subjects receiving blood transfusion within 30 days prior to study medication dosing * participation in any clinical investigation within 60 days prior to study medication dosing * continued excessive use of caffeine (caffeine \> five cups/day), severe heavy smoker (cigarette \> 10 cigarettes per day) and alcohol (alcohol\>30 g/day) * subject who has been taken meal which affect on the absorption, distribution, metabolism, excretion of drug, especially grapefruit juice * subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28 days prior to study medication dosing * continued serum potassium concentration abnormal status (on baseline visit, \ 5.5 meq/l) * subjects with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator * severe renal insufficient subjects (creatinine clearance : less than 10 ml/min) * severe hepatic insufficient subjects,billiary cirrhosis, biliary obstruction and cholestasis patient * combination with aliskiren in diabetic patient or moderate to severe renal insufficient subjects (glomerular filtration rate\<60 ml/min/1.73m2)

Keywords: amlodipine valsartan hypertension