Healthy Male Subjects
Conditions
Brief summary
The purpose of this study is to assess the pharmacokinetic characteristics of olmesartan and S-amlodipine after single oral administration of Sevikar tab. 10/40mg, a combination formulation of olmesartan and amlodipine as reference drug and Lodivikar tab. 5/40mg, a combination formulation of olmesartan and S-amlodipine as test drug in healthy male adults. Additionally the safety and tolerability of two drugs will be evaluated.
Interventions
DRUGSevikar tab. 10/40mg
Reference drug: Sevikar tab. 10/40mg, 1T, single oral administration in the fasted state
DRUGLodivikar tab. 5/40mg
Test drug: Lodivikar tab 5/40mg, 1T, single oral administration in the fasted state
Sponsors
Hanlim Pharm. Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male in the age of 20-45 * Body weight ≥ 55kg, IBW ± 20% * Subject who sign on an informed consent form willingly
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 known for hypersensitivity reaction to S-amlodipine, amlodipine and olmesartan and dihydropyridine derivatives * Clinically significant hypotension (SBP≤100mmHg, DBP≤60mmHg) or hypertension(SBP≥150mmHg, DBP≥95mmHg) when screening period * Subject with known for history of disease or gastric surgery which affect on the absorption, * Subject with any of the following conditions in laboratory test * AST or ALT \> UNL (upper normal limit) x 1.5 * Total bilirubin \> UNL x 1.5 * Renal failure with CLcr \< 50mL/min calculated on Cockcroft-Gault \[Cockcroft-Gault GFR = (140-age) \* (Wt in kg) / (72 \*Cr)\] * Serum potassium \< 3.5 mEq/L or \> 5.5 mEq/L * Continued excessive use of caffeine (caffeine \>five cups/day), alcohol(alcohol\>30g/day) and severe heavy smoker(cigarette \>10 cigarettes per day) * Participation in any clinical investigation within 60days prior to study medication dosing * Subject with whole blood donation within 60days, component blood donation within 30days prior to study medication dosing * Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing * Use of any prescription medication including oriental medication within 14 days prior to study medication dosing or over-the-counter medication within 7 days prior to study medication dosing * Subject with mental illness or drug addiction * Subject taking foods which affect on the absorption, distribution, metabolism or excretion of drug within 7days prior to study medication dosing * Subject 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 |
|---|---|
| Area under the plasma concentration versus time curve (AUC) | 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144hr(19 points) |
| Peak Plasma Concentration (Cmax) | 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144hr(19 points) |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events | From study medication dosing day to follow-up period for maximum 7 days from the second period discharge |
Countries
South Korea
Outcome results
None listed