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| Name | Class |
|---|---|
| Shanghai Institute of Materia Medica, Chinese Academy of Sciences | OTHER |
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This study is objective to evaluate the in vivo absorption, excretion and biotransformation pathways of [14C]-TPN171H in Chinese male healthy volunteers, and to reveal the overall pharmacokinetic characteristics of TPN171H in human body, so as to provide basis for rational use of the drug.
This will be an open-label, single-center study to evaluate the mass-balance and pharmacokinetics of TPN171H in approximately 6 healthy male subjects receiving a single oral 10 mg dose of TPN171H containing approximately 100 microcuries of [14C]-TPN171H. Subjects will be checked in to the research unit from approximately 24 hours prior to dosing and remain in house until greater than 80% of the administered radioactivity is collected from bodily excreta or until less than 1% of the administered radioactivity is recovered from excreta in two consecutive time intervals, and blood sample radioactivity concentration at two consecutive time points less than 3 times the plasma background value. This study will investigate the main biotransformation and elimination pathways of TPN171H in the human body and will seek to identify compound's major metabolites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]TPN171H | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]TPN171H | Drug | A single 10 mg oral dose of [14C]TPN171H containing approximately 100 microcurie of [14C]-TPN171H. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax - maximum observed plasma concentration | From time zero up to 336 hours post-dose following oral administration of [14C]TPN171H | |
| Tmax - time at which Cmax occurs | From time zero up to 336 hours post-dose following oral administration of [14C]TPN171H | |
| AUC0~t - area under the plasma concentration time curve from time zero to the last measurable concentration | From time zero up to 336 hours post-dose following oral administration of [14C]TPN171H | |
| AUC0-∞ - area under the plasma concentration-time curve from time zero to infinity | From time zero up to 336 hours post-dose following oral administration of [14C]TPN171H | |
| Total radioactivity in urine and faeces | From time zero up to 336 hours post-dose following oral administration of [14C]TPN171H |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gangyi Liu | Shanghai Xuhui Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Shanghai | China |
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