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A non-randomized, two-arm, single-sequence, crossover, open label, multiple oral dosing clinical trial to evaluate the safety and the pharmacokinetic drug-drug interaction of Telmisartan/Amlodipine and Rosuvastatin in healthy male volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference1 | Experimental | single(Reference1) -> combination(Reference1+Reference2) |
|
| Reference2 | Experimental | single(Reference2) -> combination(Reference1+Reference2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan | Drug |
| ||
| Amlodipine |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of Reference 1 | 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24hour | |
| Cmax of Reference 1 | 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24hour | |
| AUC of Reference 2 | 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hour | |
| Cmax of Reference 2 | 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hour |
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Inclusion Criteria:
Exclusion Criteria:
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|
| Rosuvastatin | Drug |
|
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| D017311 | Amlodipine |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
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