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[¹⁴C] Hydronidone Mass Balance Study

StatusCompleted
PhasePhase 1
Started
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Record History

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  1. Primary endpoints: details revised at 1 of 15 entries Show 6 more changesShow less
    • Completed without a posted recruiting period
    • Final enrollment: 6 participants (planned 8)
    • Primary completion date changed from estimate of Jul 30, 2026 to May 6, 2026
    • Start date changed from estimate of Apr 30, 2026 to Apr 17, 2026
    • Eligibility criteria expanded, about 24 words
    • Site contact updated
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
(from sponsor)		 Chronic Hepatitis B-related Liver Fibrosis
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov