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Study to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics(PK/PD)of YH12852 after oral administration in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YH12852 | Experimental | <SAD cohort>
<FSD cohort>
<MAD cohort>
|
|
| Prucalopride | Active Comparator | <each cohort> Prucalopride succinate 1.321mg |
|
| Placebo | Placebo Comparator | <each cohort> Matching Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YH12852 | Drug |
| ||
| Prucalopride |
| Measure | Description | Time Frame |
|---|---|---|
| the number of adverse events, seriousness of adverse event | D1~Post study visit | |
| significant changes in vital sign | D1~Post study visit | |
| significant changes in 12-lead electrocardiography | D1~Post study visit | |
| significant changes in laboratory test | D1~Post study visit | |
| significant physical exam | D1~Post study visit |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | 0~48 hrs(SAD,FSD cohorts), 0~24 hrs/D5,6 0hr/D7 0~48hrs(MAD cohort) | |
| AUC | 0~48 hrs(SAD,FSD cohorts), 0~24 hrs/D5,6 0hr/D7 0~48hrs(MAD cohort) | |
| Ae |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje Busan Paik hospital | Busan | 614-735 | South Korea |
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| ID | Term |
|---|---|
| C000627745 | YH12852 |
| C406662 | prucalopride |
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|
| Placebo | Drug |
|
| 0~48 hrs(SAD cohort), 0~24 hrs/D7 0~48hrs(MAD cohort) |
| BSFS | pharmacodynamics | D1~7(SAD, FSD cohorts), D1~14(MAD cohort) |
| Frequency of defecation | pharmacodynamics | D1~7(SAD, FSD cohorts), D1~14(MAD cohort) |