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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Enrolled participants fasted for at least 10 hours prior to dosing. On the morning of Day 1 (D1), a single oral dose of \[¹⁴C\]Hydronidone suspension (containing approximately 90 mg/100 μCi of \[¹⁴C\]Hydronidone) was administered under fasting conditions, with approximately 240 mL of water used for preparation and administration. Except for the water used for dosing, no water was permitted within 1 hour before and after administration. Participants remained in the isotope ward of the study center from dosing until Day 9 (D9), which could be shortened or extended depending on whether the sample collection termination criteria were met."
Beijing Gaobo Hospital
Beijing, Beijing Municipality, China
Cumulative radioactive recovery in excreta (urine and feces) per collection period
Time frame: within 9 days after dosing
Cumulative total radioactive recovery in excreta (urine and feces)
Time frame: within 9 days after dosing
Pharmacokinetic parameters of total radioactivity in plasma : Cmax
Time frame: within 9 days after dosing
Pharmacokinetic parameters of total radioactivity in plasma : Tmax
Time frame: within 9 days after dosing
Pharmacokinetic parameters of total radioactivity in plasma : t1/2
Time frame: within 9 days after dosing
Pharmacokinetic parameters of total radioactivity in plasma : MRT
Time frame: within 9 days after dosing
Pharmacokinetic parameters of total radioactivity in plasma : AUC
Time frame: within 9 days after dosing
Whole blood ratio of total radioactivity concentration
Time frame: within 9 days after dosing
plasma ratio of total radioactivity concentration
Time frame: within 9 days after dosing
Percentage of unchanged drug relative to total radioactivity exposure in plasma
Time frame: within 9 days after dosing
Percentage of unchanged drug in urine relative to the administered dose (%Dose)
Time frame: within 9 days after dosing
Percentage of unchanged drug in feces relative to the administered dose (%Dose)
Time frame: within 9 days after dosing
Identification of major metabolites in plasma
Time frame: within 9 days after dosing
Identification of major metabolites in urine
Time frame: within 9 days after dosing
Identification of major metabolites in feces
Time frame: within 9 days after dosing
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