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NOT YET RECRUITING
NCT07471217
PHASE1

[¹⁴C] Hydronidone Mass Balance Study

Sponsor: Beijing Continent Pharmaceutical Co, Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

8

Start Date

2026-04-30

Completion Date

2026-07-30

Last Updated

2026-03-13

Healthy Volunteers

Yes

Interventions

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."

Locations (1)

Beijing Gaobo Hospital

Beijing, Beijing Municipality, China