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COMPLETED
NCT07262346
PHASE1

The Phase Ⅰd Clinical Trial of Hydronidone Capsules

Sponsor: Beijing Continent Pharmaceutical Co, Ltd.

View on ClinicalTrials.gov

Summary

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.

Official title: Clinical Pharmacokinetic Study of Hydronione Capsules in Healthy Chinese Subjects (Ⅰd)

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

138

Start Date

2025-12-24

Completion Date

2026-05-28

Last Updated

2026-09-21

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Hydronidone capsules

SAD:Single-dose administration MAD:Multiple-dose group Study on the Interaction between Food and Drugs

DRUG

Placebo capsules

SAD:Single-dose administration MAD:Multiple-dose group Study on the Interaction between Food and Drugs

Locations (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China