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randomized, open-label, single dose, replicate crossover clinical trial to compare the pharmacokinetics of TAH(80/10/12.5) tablet in comparison to the co-administration of telmisartan, amlodipine and hydrochlorothiazide in healthy male volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAH(80/10/12.5) tablet | Experimental | Telmisartan/Amlodipine besylate/Hydrochlorothiazide(80/10/12.5) tablet |
|
| Telmisartan+Amlodipine besylate+Hydrochlorothiazide | Active Comparator | coadministration of Telmisartan, Amlodipine besylate and Hydrochlorothiazide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAH Tablet (Telmisartan80/Amlodipine besylate10/Hydrochlorothiazide12.5) | Drug | Telmisartan 80.0 mg, Amlodipine besylate 13.87 mg (Amlodipine 10 mg), Hydrochlorothiazide 12.5 mg combination-drug would be administered orally once |
| Measure | Description | Time Frame |
|---|---|---|
| AUClast | [Time Frame: Hour 0 (Pre-dose), Hour 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144(Total 18 points)] | |
| Cmax | [Time Frame: Hour 0 (Pre-dose), Hour 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144 (Total 18 points)] |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonbuk National University Hospital | Chonbuk | 561-712 | South Korea |
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| TWYNSTA(Telmisartan+Amlodipine besylate) | Drug | TWYNSTA 2 Tab. 40/5mg(Telmisartan 40 mg, Amlodipine besylate 6.935 mg(Amlodipine 5 mg) would be administered orally once |
|
| Hydrochlorothiazide | Drug | Dichlozid 1 Tab.(Hydrochlorothiazide 12.5 mg) would be administered orally once |
|
| ID | Term |
|---|---|
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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