Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A randomized, open-label, single-dose, two-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.
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
| 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 168 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 168 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 168 hours post dose | |
| t1/2 after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| C542574 | levamlodipine |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Telmisartan | Drug | - Telmisartan 80mg tablet, Oral, Once Daily (Combination Therapy with S-amlodipine) |
|
|
| S-amlodipine | Drug | - S-amlodipine 5mg tablet, Oral, Once Daily (combination Therapy with Telmisartan) |
|
|
| up to 168 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 168 hours post dose |
| Number of participants with adverse events |
| up to 31days post dose |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |