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The Phase Ⅰd Clinical Trial of Hydronidone Capsules

StatusCompleted
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary endpoints: details revised at 6 of 26 entries Show 5 more changesShow less
    • Completed without a posted recruiting period
    • Primary and study completion dates changed from estimate of May 5, 2026 to May 28, 2026
    • Start date changed from estimate of Dec 5, 2025 to Dec 24, 2025
    • Eligibility criteria expanded, about 27 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Based on the Phase I (Ia, Ib, Ic) clinical pharmacokinetic study of Hydronidone Capsules, a clinical pharmacokinetic trial of Hydronidone Capsules (specification: 30 mg/capsule) was conducted, including single-dose administration, multiple-dose administration, and a food-effect study. The aim was to investigate the safety, tolerability, and pharmacokinetic characteristics of higher doses of Hydronidone Capsules (specification: 30 mg/capsule) in healthy subjects, in preparation for future expansion of indications.
Trial Details
NCT Number NCT07262346
Lead Sponsor Beijing Continent Pharmaceutical Co, Ltd.
Collaborators: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions
(from sponsor)		 Liver Fibrosis
Related terms Liver Cirrhosis
Enrollment 138 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov