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This study investigates the absorption, metabolism, and excretion and the absolute bioavailability of YH12852 in healthy male subjects
Part 1 : Investigate the absorption metabolism, and excretion of YH12852 after single oral administration of YH12852 and 14C-labeled YH12852.
Part 2
: Investigate the absolute bioavailability of YH12852 after single oral administration of YH12852 followed by a single i.v. administration of 14C-labeled YH12852.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | Investigate the absorption, metabolism, and excretion of YH12852 |
|
| Part 2 | Experimental | Investigate the absolute bioavailability of YH12852 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YH12852 | Drug | YH12852 administration |
| |
| 14C-labeled YH12852 |
| Measure | Description | Time Frame |
|---|---|---|
| Total radioactivity | Total radioactivity recovered | 0 - 288 hours (post-dose) |
| Cmax of YH12852 | Peak concentration of YH12852 | 0(pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288 hours (post-dose) |
| AUClast of YH12852 | Area under the concentration-time curve from time 0 to the last measurable time of YH12852 | 0(pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288 hours (post-dose) |
| Fpo of YH12852 | Oral bioavailability of YH12852 | 0(pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288 hours (post-dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Aef of YH12852 | Amount excreted in feces of YH12852 | 0 - 288 hours (post-dose) |
| Aeu of YH12852 | Amount excreted in urine of YH12852 | 0 - 288 hours (post-dose) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Howard Lee, MD., PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital Clinical Trial Center | Seoul | South Korea |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000627745 | YH12852 |
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| Drug |
14C-labeled YH12852 administration |
|