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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R-T | Experimental | First period: administration of reference drug, Second period: administration of test drug |
|
| T-R | Experimental | First period: administration of test drug, Second period: administration of reference drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevikar tab. 10/40mg | Drug | Reference drug: Sevikar tab. 10/40mg, 1T, single oral administration in the fasted state |
|
| Measure | Description | 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) |
| Measure | Description | 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 |
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Inclusion Criteria:
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
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metrohospital | Anyang | Kyung Gi | 430-720 | South Korea |
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| Lodivikar tab. 5/40mg | Drug | Test drug: Lodivikar tab 5/40mg, 1T, single oral administration in the fasted state |
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