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 Interaction Between AD-2101 and AD-2102 in healthy male subjects.
To evaluate the pharmacokinetic Interaction, safety and tolerability of the combination compared with the administration of AD-2101 and AD-2102.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Period 1: AD-2101 Period 2: AD-2102 Period 3: AD-2101 + AD-2102 |
|
| Sequence 2 | Experimental | Period 1: AD-2101 Period 2: AD-2101 + AD-2102 Period 3: AD-2102 |
|
| Sequence 3 | Experimental | Period 1: AD-2102 Period 2: AD-2101 Period 3: AD-2101 + AD-2102 |
|
| Sequence 4 | Experimental | Period 1: AD-2102 Period 2: AD-2101 + AD-2102 Period 3: AD-2101 |
|
| Sequence 5 | Experimental | Period 1: AD-2101 + AD-2102 Period 2: AD-2101 Period 3: AD-2102 |
|
| Sequence 6 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AD-2101 | Drug | AD-2101 16/5mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration | Cmax,ss of the total ingredient of AD-2101 and AD-2102 | pre-dose to 24 hours |
| Area under the plasma concentration versus time curve | AUCt,ss of the total ingredient of AD-2101 and AD-2102 | pre-dose to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach Cmax | Tmax,ss of the total ingredient of AD-2101 and AD-2102 | pre-dose to 24 hours |
| Clearance | CLss/F of the total ingredient of AD-2101 and AD-2102 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| HyeWon Chung | Korea University Guro Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Seoul | South Korea |
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Experimental |
Period 1: AD-2101 + AD-2102 Period 2: AD-2102 Period 3: AD-2101 |
|
| AD-2102 | Drug | AD-2102 25mg |
|
| AD-2101 + AD-2102 | Drug | AD-2101 16/5mg + AD-2102 25mg |
|
| pre-dose to 24 hours |
| Bottom Plasma Concentration | Cmin,ss of the total ingredient of AD-2101 and AD-2102 | pre-dose to 24 hours |
| Number of participants with adverse events | Incidence rate of adverse events | From Day 1 up to Day 66 |