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This is a Randomized, open-label, single-dose, 2-treatment, 2-period, 2-sequence crossover design.
This is a 2 by 2 cross-over study to evaluate pharmacokinetics of YH22162 FDC compared to reference twynsta and Hygroton co-administered in two 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 YH22162 FDC or twynsta and Hygroton co-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 two treatment periods will be separated by a washout period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Period 1 | Active Comparator | Telmisartan/Amlodipine 80/5 mg (FDC) and Chlorthalidone 25mg |
|
| Group 2 - Period 1 | Experimental | YH22162 FDC tablet of Yuhan Corporation |
|
| Group 1 - Period 2 | Experimental | YH22162 FDC tablet of Yuhan Corporation |
|
| Group 2 - Period 2 | Active Comparator | Telmisartan/Amlodipine 80/5 mg (FDC) and Chlorthalidone 25mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YH22162 | Drug |
| ||
| Telmisartan/Amlodipine 80/5 mg (FDC) |
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence study is based on Cmax and AUC parameters | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mingul Kim, MD, Ph.D | 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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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| D017311 | Amlodipine |
| D002752 | Chlorthalidone |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
|
|
| Chlorthalidone 25mg | Drug |
|
|
| 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 |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D001577 | Benzophenones |
| D010797 | Phthalimides |
| D007094 | Imides |
| D007659 | Ketones |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D054833 | Isoindoles |