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To analyze radioactivity excretion and pharmacokinetics in healthy subjects after a single oral dose of [¹⁴C]TQ05105, identifying excretion routes, major metabolites, and biotransformation pathways. Secondary: To determine pharmacokinetics of TQ05105 and metabolites (e.g., TQ12550) via Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) and assess treatment safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQ05105 | Experimental | Take the [14C]TQ05105 suspension under fasting conditions, ensuring the entire dose is administered within 5 minutes. The total water volume used for drug preparation and administration is approximately 240 mL. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQ05105 | Drug | Janus Kinase 2 (JAK2) inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| loss rate | Total radioactive recovery rate and cumulative total radioactive recovery rate in excreta (urine and feces) for each time interval. | From 24 hours prior to administration to 504 hours post-administration |
| Peak concentration (Cmax) | Maximum plasma drug concentration | Before administration, 0.16, 0.33, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, 336 hours after administration |
| Area under drug time curve (AUC0-∞) | Area under the plasma concentration-time curve from time 0 extrapolated to infinite time | Before administration, 0.16, 0.33, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, 336 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event rate | Incidence and severity of adverse events and serious adverse events, and abnormal laboratory examination indicators. | From before the first administration to 7 days after the administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangnan University Affiliated Hospital | Wuxi | Jiangsu | 214122 | China |
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