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This is a phase 1, open label, single-dose, crossover study to investigate the pharmacokinetics of YHP1604 in comparison to the co-administration of telmisartan/amlodipine and rosuvastatin in healthy male volunteers
Hypothesis: "YHP1604" and "telmisartan/amlodipine and rosuvastatin" are showing equal pharmacokinetics.
This is a phase 1, open label, single-dose, crossover study to investigate the pharmacokinetics of YHP1604 in comparison to the co-administration of telmisartan/amlodipine and rosuvastatin in healthy male volunteers.
In ARM1, 30 subjects will be assigned and the subjects will be administered "telmisartan/amlodipine and rosuvastatin" at Day1 and "YHP1604" at Day22.
In ARM2, 30 subjects will be assigned and the subjects will be administered "YHP1604" at Day1 and "telmisartan/amlodipine and rosuvastatin" at Day22.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM1 | Other | In ARM1, 30 subjects will be assigned and the subjects will be administered "telmisartan/amlodipine and rosuvastatin" at Day1 and "YHP1604" at Day22. |
|
| ARM2 | Other | In ARM2, 30 subjects will be assigned and the subjects will be administered "YHP1604" at Day1 and "telmisartan/amlodipine and rosuvastatin" at Day22. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temisartan/Amlodipine+Rosuvastatin | Drug | All subjects will receive a single oral dose of temisartan/amlodipine+rosuvastatin administered in the morning. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Telmisartan/Amlodipine/Rosuvastatin Cmax, AUClast | Cmax, AUClast | 0 - 72 hrs, 0 - 168 hrs, 0 - 48 hrs |
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Inclusion Criteria:
Exclusion Criteria:
Healthy male with body mass index(BMI) between 18.5 and 30kg/m2
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| Name | Affiliation | Role |
|---|---|---|
| Mingul Kim, MD | Chonbuk National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonbuk National University Hospital | Jeonju | 561-712 | South Korea |
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A randomized, open-label, single dose, crossover clinical trial
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|
| YHP1604 | Drug | All subjects will receive a single oral dose of YHP1604 administered in the morning. |
|
|
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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