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A randomized, open-label, multiple-dose, crossover study to investigate the pharmacokinetic drug interaction between rosuvastatin and telmisartan/amlodipine in healthy male volunteers
A randomized, open-label, 2-treatment, 2-sequence, 2-period, multiple-dose, crossover design
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 of part 1 | Experimental | Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T during the period 1 and Rosuvastatin 20mg 1T and Telmisartan/Amlodipine 40/5mg 2T during the period 2 |
|
| Group 2 of part 1 | Experimental | Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Rosuvastatin 20mg 1T during the period 2 |
|
| Group 1 of part 2 | Experimental | Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 2 |
|
| Group 2 of part 2 | Experimental | Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Telmisartan/Amlodipine 40/5mg 2T during the period 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin once daily for 9 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCÏ„,ss , Cmax, ss of Rosuvastatin and Telmisartan, Amlodipine | 72hours, 144hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUClast,ss of Rosuvastatin | 72hours | |
| AUCinf,ss of Rosuvastatin | 72hours | |
| Tmax,ss of Rosuvastatin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyungsoo Park, MD, Ph.D. | Yonsei University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Health System | Seoul | Seodaemun-gu | 120-752 | South Korea |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| C548840 | telmisartan amlodipine combination |
| D000077333 | Telmisartan |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Telmisartan/Amlodipine | Drug | Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine once daily for 9 days |
|
|
| Rosuvastatin and Telmisartan/Amlodipine | Drug | Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin and Telmisartan/Amlodipine once daily for 9days |
|
|
| 72hours |
| t1/2 of Rosuvastatin | 72hours |
| AUClast,ss of Telmisartan, Amlodipine | 144hours |
| AUCinf,ss of Telmisartan, Amlodipine | 144hours |
| Tmax,ss of Telmisartan, Amlodipine | 144hours |
| t1/2 of Telmisartan, Amlodipine | 144hours |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |