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

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

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

Details

• Lead Sponsor: CJ HealthCare Corporation; HK inno.N Corporation
• Treatments: Amlodipine; Amlodipine, Valsartan Drug Combination; Lactitol; Valsartan

Criteria

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