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
Not provided
The purpose of this study is to evaluate the pharmacokinetic characteristics of CKD-828 (Fixed Dose Combination Tablet; Telmisartan and S-Amlodipine) in healthy volunteer.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CKD-828(Fixed Dose Combination) | Experimental | Single oral dose of a FDC tablet consisting of Telmisatan 40mg/S-Amlodipine 5mg Intervention |
|
| Free combination Therapy | Active Comparator | Co-administration of single oral doses of a 40mg tablet of Telmisatan and a 5 mg tablet of S-Amlodipine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-828 | Drug | Drug: Telmisartan 40mg + S-Amlodipine 5mg(FDC) Tablet, Oral, Once Daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax after administration of CKD-828(Fixed Dose Combination) tablet and co-administration of corresponding dose of Telmisartan and S-Amlodipine as individual tablets. | up to 168 hours postdose | |
| The area under the plasma concentration-time curve (AUC) after administration of CKD-828(Fixed Dose Combination) tablet and co-administration of corresponding dose of Telmisartan and S-Amlodipine as individual tablets. | up to 168 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax and t1/2 after administration of CKD-828(Fixed Dose Combination) tablet and co-administration of corresponding dose of Telmisartan and S-Amlodipine as individual tablets. | up to 168 hours postdose | |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eunyoung Kim | Inje University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Pusan Paik Hospital | Pusan | South Korea |
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Combination Therapy | Drug | Drug: Telmisartan 40mg Tablet, Oral, Once Daily Drug: S-amlodipine 5mg Tablet, Oral, Once Daily |
|
| up to 22days |