Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07262333
PHASE1

A Trial of Hydroxynidone Capsules in Single-dose Administration for Patients With Renal Insufficiency

Sponsor: Beijing Continent Pharmaceutical Co, Ltd.

View on ClinicalTrials.gov

Summary

Hydronidone capsules are pyridinone-based small molecule compounds. Hydronidone has not been approved for commercial sale both domestically and internationally. The applicant has completed the preliminary Phase I and Phase II clinical trials. The results showed that Hydronidone is a safe and effective drug for treating liver fibrosis in chronic hepatitis B, and it has good safety and tolerability. Based on the preliminary clinical research, a special population study has been initiated. The aim is to investigate the pharmacokinetic differences and safety of honginone capsules in patients with renal insufficiency and healthy subjects, in order to provide a basis for the clinical medication of patients with renal dysfunction.

Official title: Safety and Pharmacokinetics of Single-dose Hydroxynidone Capsules in Patients With Renal Insufficiency

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2025-12-25

Completion Date

2026-07-01

Last Updated

2026-04-06

Healthy Volunteers

Yes

Interventions

DRUG

Hydronidone capsules

Take 90mg orally on an empty stomach on Day 1.

Locations (1)

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

Hubei, Wuhan, China