Clinical trial to assess the pharmacokinetic characteristics of Lodivixx tab. 5/160mg in healthy male subjects

Recruitment & Eligibility

Status: Recruiting

Sex: Male

Target Recruitment: 40

Inclusion Criteria

1) Years 20-45
2) Body weight=50kg and 18=BMI=29kg/m2
3) volunteer

Exclusion Criteria

1) Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
2) Subject with symptoms of acute disease within 28days prior to study medication dosing
3) Subject with known for history which affect on the absorption, distribution, metabolism or excretion of drug
4) Subject with clinically significant active chronic disease
5) 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. reanl failure with Creatinine clearance < 50mL/min
6) Clinically significant hypotension when screening period (SBP<100mmHg, DBP<60mmHg)
7) Positive test results for HBs Ab, HCV Ab, Syphilis regain test
8) Use of any prescription medication within 14 days prior to study medication dosing
9) Use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing
10) Subject with clinically significant allergic disease (except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug)
11) Subject with known for hypersensitivity reaction to S-amlodipine, amlodipine and valsartan and dihydropyridine derivatives
12) Subject who is not able to taking the institutional standard meal
13) Subjects with whole blood donation within 60days, component blood donation within 20days
14) Subjects receiving blood transfusion within 30days prior to study medication dosing
15) Participation in any clinical investigation within 60days prior to study medication dosing
16) Continued excessive use of caffeine (caffeine > five cups/day), alcohol(alcohol>30g/day) and severe heavy smoker(cigarette > 10 cigarettes per day)
17) Subject who has been taken meal which affect on the absorption, distribution, metabolism, excretion of drug, especially grapefluit juice
18) Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital wihin 28days prior to study medication dosing
19) Contined serum potassium concentration abnormal status (on baseline visit, <3.5mEq/L or >5.5mEq/L)
20) Subjects with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to requst or instruction by investigator

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pharmacokinetic evaluation(Cmax, AUCt)

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability evaluation

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