Phase Ⅰ Study to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg Tablet and Novartis Exforge 10/160mg Tablet

HK inno.N

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: CJ Amlodipine/Valsartan 10/160mg Novartis Exforge 10/160mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01735890

CJ_AMV_102

Details and patient eligibility

About

The objectives of this study are:

To compare the safety profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers
To compare the pharmacokinetic profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers

Enrollment

48 patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Years 20-45
18 ≤ BMI < 27kg/m²
volunteer

Exclusion criteria

Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing
Subject with symptoms of acute disease within 28days prior to study medication dosing
Subject with gastrointestinal diseases or surgery which might significantly change absorption of medicines
Use of any prescription medication within 14 days prior to study medication dosing and over-the-counter medication including oriental medication within 7 days prior to study medication dosing
Subject with known for hypersensitivity reaction to amlodipine and valsartan
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. eGFR< 50mL/min ⅳ. continued serum potassium concentration abnormal status (on baseline visit, < 3.5mEq/L or > 5.5mEq/L)
Positive test results for HBs Ab, HCV Ab, Syphilis regain test
Drug abuse or continued excessive use of caffeine (caffeine > five cups/day), severe heavy smoker (cigarette > 10 cigarettes per day) and alcohol(alcohol>30g/day)
Subject who has been taken meal which affect on the absorption, distribution, metabolism, excretion of drug, especially grapefruit juice
Clinically significant hypotension(SBP < 100mmHg, DBP ≤65mmHg) or hypertension(SBP 100mmHg, DBP < 65mmHg) when screening period
Participation in any clinical investigation within 60days prior to study medication dosing
Subjects with whole blood donation within 60days, component blood donation within 20days and blood transfusion within 30days prior to study medication dosing
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