NCT07471217

[¹⁴C] Hydronidone Mass Balance Study

[¹⁴C] Hydronidone Mass Balance Study in Chinese Healthy Adult Male Participants

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Beijing Continent Pharmaceutical Co, Ltd. · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Hepatitis B-related Liver Fibrosis

Interventions

Type	Name	Description
DRUG	[¹⁴C]Hydronidone	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."

Timeline

• Start date: 2026-04-30
• Primary completion: 2026-07-30
• Completion: 2026-07-30
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

1 site across 1 country: China