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A randomized, open-label, single-dose, four-period, two-way, crossover study,
A randomized, open-label, single-dose, four-period, two-way, crossover study to compare the pharmacokinetics and safety CKD-828 (Fixed Dose Combination Tablet) to coadministration telmisartan and s-amlodipine in health volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CKD-828(Fixed Dose Combination) | Experimental | FDC tablet consisting of Telmisartan 80mg/S-Amlodipine 5mg |
|
| Combination Therapy | Active Comparator | Coadministration of Telmisartan 80mg and S-amlodipine 5mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-828 | Drug | Telmisartan 80mg /S-Amlodipine 5mg(FDC) Tablet, Oral, Once Daily (1arm:2period and 4period, 2arm:1period and 3period) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine. | up to 144 hours post dose | |
| AUClast after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine. | up to 144 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine. | up to 144 hours post dose | |
| t1/2 after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Young-Ran Yoon | Kyungpook National University Hospital Clinical Trial Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University Hospital | Daegu, Samdeok-dong, 2-ga 50 | Samdeok-dong, 2-ga 50 Jung-gu | 700-721 | 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 |
| C542574 | levamlodipine |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Telmisartan | Drug | - Telmisartan 80mg tablet, Oral, Once Daily (Combination Therapy with S-amlodipine) (1arm:1period and 3period, 2arm: 2period and 4period) |
|
|
| S-amlodipine | Drug | - S-amlodipine 5mg tablet, Oral, Once Daily (combination Therapy with Telmisartan) (1arm:1period and 3period, 2arm: 2period and 4period) |
|
|
| up to 144 hours post dose |
| AUCinf after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine. | up to 144 hours post dose |
| Number of participants with adverse events | - Adverse Event monitoring | up to 59days post dose |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |