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The purpose of this study is to compare the safety and pharmacokinetics of HL068 (Candesartan 16 mg and Amlodipine 10mg) with coadministration of the two separate drugs in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Candesartan 16mg and Amlodipine 10mg | Experimental | Candesartan 16mg and Amlodipine 10mg |
|
| HL068 | Experimental | HL068(combination of Candesartan 16 mg and Amlodipine 10 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HL068 16/10mg | Drug | Candesartan 16mg and Amlodipine 10mg |
| |
| Candesartan 16mg and Amlodipine 10mg |
| Measure | Description | Time Frame |
|---|---|---|
| AUCt | up to 72 hours | |
| Cmax | up to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf | up to 72 hours | |
| Tmax | up to 72 hours | |
| t 1/2β |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Young-Ran Yoon, M.D, Ph.D | KYUNGPOOK NATIONAL UNIVERSITY HOSPITAL CLINICAL TRIAL CENTER | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32656160 | Derived | Lee HW, Kang WY, Jung W, Gwon MR, Yang DH, Kim EH, Cho K, Yoon YR, Seong SJ. Pharmacokinetics and bioequivalence of fixed-dose combination of candesartan cilexetil/amlodipine besylate (16/10 mg) versus coadministration of individual formulations in healthy subjects. Transl Clin Pharmacol. 2020 Jun;28(2):92-101. doi: 10.12793/tcp.2020.28.e8. Epub 2020 Jun 24. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C081643 | candesartan |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
|
| up to 72 hours |
| CL/F | up to 72 hours |