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This is a Randomized, open-label, single-dose, 3-treatment, 3-period, 3-sequence crossover design.
This is a 6 by 3 cross-over study to evaluate pharmacokinetics of YH22189 FDC compared to reference telmisartan/amlodipine and rosuvastatin co-administered in three groups enrolling healthy adult male subjects under fasting conditions.
Subjects will be admitted to the clinic in the evening before Day 1. All subjects will receive a single oral dose of YH22189 FDC or telmisartan/amlodipine or rosuvastatin administered in the morning on Day 1. All the subjects will remain in the clinical unit until completion of all assessments on Day 2 including collection post-dose PK sample. Subjects will return to the clinic for pharmacokinetic samples at scheduled time. The three treatment periods will be separated by a washout period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YH22189 | Experimental | YH22189 FDC tablet of Yuhan Corporation |
|
| Twynsta 80/10mg | Active Comparator | Telmisartan/Amlodipine 80/10mg (FDC) |
|
| Crestor 20mg | Active Comparator | Rosuvastatin 20mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YH22189 | Drug |
| ||
| Twynsta 80/10mg |
| Measure | Description | Time Frame |
|---|---|---|
| Telmisartan Cmax | 0 - 72 hrs | |
| Telmisartan AUClast | 0 - 72 hrs | |
| Amlodipine Cmax | 0 - 168 hrs | |
| Amlodipine AUClast | 0 - 168 hrs | |
| Rosuvastatin Cmax | 0 - 48 hrs | |
| Rosuvastatin AUClast | 0 - 48 hrs |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonbuk National University Hospital | Jeonju | 561-712 | 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 |
|---|---|
| C548840 | telmisartan amlodipine combination |
| D000077333 | Telmisartan |
| D017311 | Amlodipine |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
|
| Crestor 20mg | Drug |
|
|
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| 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 |