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An open-label, randomized, fasting, single-dose, oral administration, 2-sequence, 4-period, replicate crossover study to evaluate bioequivalence between YHP2508C and YHR2603 in healthy subjects
44 healthy subjects will be randomized to one of 2 groups in the same ratio.
Subjects in group 1 will be administered "YHR2603" and "YHP2508C" by crossover design on periods 1 to 4.
Subjects in group 2 will be administered "YHP2508C" and " YHR2603" by crossover design on periods 1 to 4.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A(RTRT) | Experimental | 22 subjects, Cross-over, Single dose YHR2603 on period 1 and 3, Single dose of YHP2508C on period 2 and 4. |
|
| B(TRTR) | Experimental | 22 subjects, Cross-over, Single dose YHP2508C on period 1 and 3, Single dose of YHR2603 on period 2 and 4. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YHP2508C | Drug | Test drug |
| |
| YHR2603 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma drug concentration-time curve [AUCt] | Area under the plasma drug concentration-time curve [AUCt] of Amlodipine, Telmisartan & Chlorthalidone | 0-72 hours |
| Maximum plasma concentration [Cmax] | Maximum plasma concentration [Cmax] of Amlodipine, Telmisartan & Chlorthalidone | 0-72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] | Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] of Amlodipine, Telmisartan & Chlothalidone | 0-72 hours |
| Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jungwook Lee, MS | Contact | 82-2-828-0504 | clinicaltrials@yuhan.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| GIMPO WOORI HOSPITAL | 11, Gamam-ro, Gimpo-si, Gyeonggi-do, Republic of Korea | Principal Investigator |
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| Drug |
Comparator drug |
|
Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf] of Amlodipine, Telmisartan & Chlorthalidone |
| 0-72 hours |
| Time of peak concentration [Tmax] | Time of peak concentration [Tmax] of Amlodipine, Telmisartan & Chlorthalidone | 0-72 hours |
| Terminal phase of half-life [t1/2] | Terminal phase of half-life [t1/2] of Amlodipine, Telmisartan & Chlorthalidone | 0-72 hours |