According to the "Technical Guidelines for Radioactive Labeled Human Mass Balance Studies" issued by the NMPA, human mass balance studies are an important component of clinical pharmacology research for innovative drugs, and it is recommended that mass balance studies be conducted for all new molecular entities. Therefore, to further clarify the absorption, metabolism, and excretion characteristics of Hydronidone in the human body, a \[¹⁴C\] Hydronidone mass balance study is planned in Chinese healthy adult male participants. This study aims to reveal the pharmacokinetic characteristics of Hydronidone and provide a reference for the rational use of the drug.
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Cumulative radioactive recovery in excreta (urine and feces) per collection period
Timeframe: within 9 days after dosing
Cumulative total radioactive recovery in excreta (urine and feces)
Timeframe: within 9 days after dosing
Pharmacokinetic parameters of total radioactivity in plasma : Cmax
Timeframe: within 9 days after dosing
Pharmacokinetic parameters of total radioactivity in plasma : Tmax
Timeframe: within 9 days after dosing
Pharmacokinetic parameters of total radioactivity in plasma : t1/2
Timeframe: within 9 days after dosing
Pharmacokinetic parameters of total radioactivity in plasma : MRT
Timeframe: within 9 days after dosing
Pharmacokinetic parameters of total radioactivity in plasma : AUC
Timeframe: within 9 days after dosing
Whole blood ratio of total radioactivity concentration
Timeframe: within 9 days after dosing
plasma ratio of total radioactivity concentration
Timeframe: within 9 days after dosing
Percentage of unchanged drug relative to total radioactivity exposure in plasma
Timeframe: within 9 days after dosing
Percentage of unchanged drug in urine relative to the administered dose (%Dose)
Timeframe: within 9 days after dosing
Percentage of unchanged drug in feces relative to the administered dose (%Dose)
Timeframe: within 9 days after dosing
Identification of major metabolites in plasma
Timeframe: within 9 days after dosing
Identification of major metabolites in urine
Timeframe: within 9 days after dosing
Identification of major metabolites in feces
Timeframe: within 9 days after dosing