Radiolabeled drug substance balance clinical studies are commonly used methods to elucidate the metabolic and excretion characteristics of drugs in the human body. They are widely applied in the research and development of innovative drugs both domestically and internationally, and their safety has been validated through extensive human trials. The primary objectives of this study are as follows: To quantitatively analyze the total radioactive activity (TRA) in urine and feces, thereby determining the radioactive recovery rate in humans and identifying the primary excretion pathways. To obtain radioactive metabolite profiles in human plasma, urine, and feces, identify the major metabolites, and determine the principal metabolic and elimination pathways. To quantitatively analyze the total radioactive activity in whole blood and plasma, derive the pharmacokinetic parameters for total radioactivity in plasma and whole blood (if applicable), and investigate the distribution of total radioactivity between whole blood and plasma.
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Percentage of unchanged drug and its metabolites in plasma, urine and feces to the administered dose
Timeframe: 2 weeks
Total recovery in excrement (the ratio of the radioactivity in excrement samples to the radioactivity of the administered drug)
Timeframe: 2 weeks
Total Radioactivity of D-2570 in Plasma and Whole Blood
Timeframe: baseline to 2 weeks
Whole blood/plasma ratio for TRA (total radioactivity) at different time points
Timeframe: Baseline to 2 weeks