A Randomized, Open-label, Single-Dose, 2-Treatment, 2-Way, 2-Period Crossover Study to Assess the Safety and the Pharmacokinetic Characteristics of Lodivikar tab. 5/40 mg in Healthy Adult Male Subjects
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0001252
- Lead Sponsor
- Hanlim Pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 32
1) Years 20-45, healthy male
2) Body weight=55kg and IBW=± 20%
3) Subject judged suitable by physical examination and interview conducted in accordance with this study protocol
4) Subject judged suitable by clinical laboratory tests and ECG
5) volunteer
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 known for hypersensitivity reaction to S-amlodipine, amlodipine and olmesartan and dihydropyridine derivatives
3) Clinically significant hypotension(SBP=100mmHg, DBP=60mmHg) or hypertension(SBP=150mmHg, DBP=95mmHg) when screening period
4) Subject with known for history of gastrointestinal disease or gastrointestinal surgery which affect on the absorption drug
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) Continued excessive use of caffeine (caffeine > five cups/day), alcohol(alcohol>30g/day) and severe heavy smoker(cigarette > 10 cigarettes per day)
7) Participation in any clinical investigation within 60days prior to study medication dosing
8) Subjects with whole blood donation within 60days, component blood donation within 30days
9) Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital wihin 28days prior to study medication dosing
10) Use of any prescription medication within 14 days prior to study medication dosing or use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing
11) psychiatric disorder, drug addiction
12) Subject who has been taken meal which affect on the absorption, distribution, metabolism, excretion of drug, especially grapefluit juice within 14 days prior to study medication dosing
13) 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
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