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 study to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers
A sequence-randomized, open-label, 3-way crossover, single oral dose clinical trial to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Period 1: CKD-386 formulation 1(1 tab, once) / Period 2: CKD-386 formulation 2(1 tab, once) / Period 3: D326, D337, D013(3 tabs, once) |
|
| Sequence 2 | Experimental | Period 1: CKD-386 formulation 1(1 tab, once) / Period 2: D326, D337, D013(3 tabs, once) / Period 3: CKD-386 formulation 2(1 tab, once) |
|
| Sequence 3 | Experimental | Period 1: CKD-386 formulation 2(1 tab, once) / Period 2: D326, D337, D013(3 tabs, once) / Period 3: CKD-386 formulation 1(1 tab, once) |
|
| Sequence 4 | Experimental | Period 1: CKD-386 formulation 2(1 tab, once) / Period 2: CKD-386 formulation 1(1 tab, once) / Period 3: D326, D337, D013 |
|
| Sequence 5 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-386 formulation 1 | Drug | A single oral dose of 1 tablet under fasting conditions for each period |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013 | AUC0-t: Area under the concentration-time curve from time zero to time | 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31 |
| Cmax of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013 | Cmax: Maximum plasma concentration of the drug | 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31 |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013 | AUCinf: Area under the concentration-time curve from zero up to ∞ | 0(predose)~72 hour at Day1~D3, Day15~D17, Day29~31 |
| Tmax of each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dongseong Shin, M.D, Ph.D | Contact | +82-32-460-9459 | dsshin@gilhospital.com |
| Name | Affiliation | Role |
|---|---|---|
| Dongseong Shin, M.D, Ph.D | Clinical Trials Center, Gil Medical Center, Incheon, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gachon University Gil Medical Center | Recruiting | Incheon | 21565 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Period 1: D326, D337, D013(3 tabs, once) / Period 2: CKD-386 formulation 1(1 tab, once) / Period 3: CKD-386 formulation 2(1 tab, once)
|
| Sequence 6 | Experimental | Period 1: D326, D337, D013 (3 tabs, once)/ Period 2: CKD-386 formulation 2(1 tab, once) / Period 3: CKD-386 formulation 1(1 tab, once) |
|
|
| CKD-386 formulation 2 | Drug | A single oral dose of 1 tablet under fasting conditions for each period |
|
|
| D326, D337 and D013 | Drug | A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period |
|
|
Tmax: Time to maximum plasma concentration |
| 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31 |
| t1/2 of each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013 | t1/2: Terminal elimination half-life | 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31 |
| CL/F of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013 | CL/F: Apparent total body clearance of the drug | 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31 |
| Vd/F of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013 | Vd/F: Apparent volume of distribution | 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31 |
| AUC0-t of the metabolite of each component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013 | AUC0-t: Area under the concentration-time curve from time zero to time | 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31 |
| Cmax of the metabolite of each component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013 | Cmax: Maximum plasma concentration of the drug | 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided