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, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2511 and YHP2511A in healthy volunteers
60 healthy subjects will be randomized to one of the 2 groups in the same ratio.
Subjects in group 1 will be administered "comparator" and "YHP2511" by crossover design on period 1, 2. Subjects in group 2 will be administered "YHP2511" and "comparator" by crossover design on period 1, 2.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A (RT) | Experimental | 30 subjects, Cross-over, Single dose YHP2511A on period 1, Single dose of YHP2511 on period 2 |
|
| B (TR) | Experimental | 30 subjects, Cross-over, Single dose YHP2511 on period 1, Single dose of YHP2511A on period 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YHP2511 | Drug | Test drug: YHP2511, Comparator: YHP2511A |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma drug concentration-time curve [AUCt] | Area under the plasma drug concentration-time curve [AUCt] of Pitavastatin & Total Ezetimibe | Pitavastatin : 0-72 hours, Total Ezetimibe: 0-72 hours |
| Maximum plasma concentration [Cmax] | Maximum plasma concentration [Cmax] of - Pitavastatin & Total Ezetimibe | Pitavastatin: 0-48 hours, Total Ezetimibe: 0-72 hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yujin Kim | Contact | 82-2-828-0394 | clinicaltrials@yuhan.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| Seoung Hyun Kang | H Plus Yangji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H Plus Yangji Hospital | Recruiting | Seoul | 08779 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| YHP2511A |
| Drug |
Test drug: YHP2511, Comparator: YHP2511A |
|