Clinical Trial

[¹⁴C] Hydronidone Mass Balance Study

Not Yet Recruiting Phase 1
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Record status
This record was last updated March 13, 2026 (before its estimated July 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Trial Details
NCT Number NCT07471217
Lead Sponsor Beijing Continent Pharmaceutical Co, Ltd.
Conditions Chronic Hepatitis B-related Liver Fibrosis
Enrollment 8 participants
Start Date 2026-04-30
Primary Completion 2026-07-30 (estimated)
Study Completion 2026-07-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-13