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| Name | Class |
|---|---|
| Inje University | OTHER |
An Open-label, Fixed-sequence, Crossover Study to Evaluate the Pharmacokinetic Interaction and Safety after multiple oral doses of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects.
After subjects have signed informed consent voluntarily, they go through screening period for within 28 days.
As period I, subjects of Cohort1 take fimasartan and Amlodipine for 10 days and subjects of Cohort2 take rosuvastatin for 6 days.
And then, as period II, subjects of both Cohorts take fimasartan, Amlodipine and rosuvastatin in Cohort1 case for 6 days and in Cohort2 case for 10 10days.
For Fimasartan, subjects of Cohort1 have blood sampling 8th, 9th, 14th, 15th day before medication, 10th and 16th day before and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24hour after medication(32 times in total).
For Amlodipine, subjects of Cohort1 have blood sampling 8th, 9th, 14th, 15th day before medication, 10th and 16th day before and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 24hour after medication(30 times in total).
For Rosuvastatin and N-desmethyl rosuvastatin, subjects of Cohort2 have blood sampling 4th, 5th, 14th, 15th day before medication, 6th and 16th day before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 and 24hour after medication(28 times in total).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort1 | Other | Treatment AB → ABC Treatment A+B (10days) → Treatment A+B+C (6days) Treatment A: Fimasartan Treatment B: Amlodipine Treatment C: Rosuvastatin |
|
| Cohort2 | Other | Treatment C → ABC Treatment C (6days) → Treatment A+B+C (10days) Treatment A: Fimasartan Treatment B: Amlodipine Treatment C: Rosuvastatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fimasartan | Drug |
| ||
| Amlodipine |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,ss | When 1 cohort, it's a measure on Fimasartan and Amlodipine. and when another cohort, it's a measure on Rosuvastatin | Time Frame: 0~24 hour after medication |
| AUC tau,ss | When 1 cohort, it's a measure on Fimasartan and Amlodipine. and when another cohort, it's a measure on Rosuvastatin | Time Frame: 0~24 hour after medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Busan Paik Hospital | Busan, Korea, Republic of | South Korea |
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|
| Rosuvastatin | Drug |
|
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C558933 | fimasartan |
| D017311 | Amlodipine |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
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