Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects (N=60)

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hanlim Pharm. Co., Ltd.
• Treatments: Amlodipine; Amlodipine, Valsartan Drug Combination; Valsartan

Criteria

Inclusion Criteria:

• Years 20-45

• Body weight ≥ 50kg and 18 ≤ BMI ≤ 29kg/m2

• volunteer

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 28days prior to study medication dosing

• Subject with known for 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 dosing

• 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 60days, component blood donation within 20days

• Subjects receiving blood transfusion within 30days prior to study medication dosing

• Participation in any clinical investigation within 60days prior to study medication dosing

• Continued excessive use of caffeine (caffeine > five cups/day), alcohol(alcohol>30g/day) and severe heavy smoker (cigarette > 10 cigarettes per 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 28days prior to study medication dosing

• Continued serum potassium concentration abnormal status (on baseline visit, < 3.5mEq/L or > 5.5mEq/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 10mL/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<60mL/min/1.73m2)