Healthy Male Subjects
Conditions
Brief summary
To assess the pharmacokinetic characteristics of Lodivixx tab.5/160mg in healthy male subjects * PK parameter evaluation * Safety profile evaluation
Interventions
Sponsors
Hanlim Pharm. Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax (maximum concentration) | - Valsartan evaluation : 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48hr (14 points) - S-Amlodipine : 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 120, 168 (17 points) |
| AUC(area under curve) | - Valsartan evaluation : 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48hr (14 points) - S-Amlodipine : 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 120, 168 (17 points) |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events | Participants will be followed for the duration of hospital stay, an expected average of 3 days and follow-up period for maximum 6 days from the discharge |
Countries
South Korea
Outcome results
None listed