Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects (N=27)

Hanlim Pharm

Status and phase

Completed

Phase 1

Conditions

Healthy Male Subjects

Treatments

Drug: Lodivixx tab. 5/160mg

Drug: Exforge tab. 10/160mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT03648333

HL-LDV-103

Details and patient eligibility

About

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

Full description

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.

Enrollment

27 patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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, < 3.5 mEq/L or > 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)