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This is a phase 1, randomized, open label, single-dose, replicate crossover clinical trial to compare the safety and pharmacokinetics of YH22162 in healthy male volunteers.
Hypothesis: Study drug and comparator drug are showing equal pharmacokinetics.
In ARM1, 32 subjects will be assigned and the subjects will be administered "comparator drug" at Day1/Day43 and "study drug" at Day22/64.
In ARM2, 32 subjects will be assigned and the subjects will be administered "study drug" at Day1/Day43 and "comparator drug" at Day22/64.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM1 | Experimental | In ARM1, 32 subjects will be assigned and the subjects will be administered "comparator drug" at Day1/Day43 and "study drug" at Day22/64. |
|
| ARM2 | Experimental | In ARM2, 32 subjects will be assigned and the subjects will be administered "study drug" at Day1/Day43 and "comparator drug" at Day22/64. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg | Drug | White colored oval three-layer tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUClast of Telmisartan/amlodipine/chlorthalidone | AUClast | 0-168 hrs |
| Cmax of Telmisartan/amlodipine/chlorthalidone | Cmax | 0-168 hrs |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf of Telmisartan/amlodipine/chlorthalidone | AUCinf | 0-168 hrs |
| Tmax of Telmisartan/amlodipine/chlorthalidone | Tmax | 0-168 hrs |
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Inclusion Criteria:
Exclusion Criteria:
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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 | Jeollanam-do | 54907 | 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 |
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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Randomized, open-label, single-dose, 2-treatment, 2-sequence, 4-period replicate crossover design
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| Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg | Drug | White and pink colored oval two-layer tablet |
|
|
| t1/2 of Telmisartan/amlodipine/chlorthalidone | t1/2 | 0-168 hrs |
| 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 |
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |