NCT07295873

Drug-Drug Interaction Study Between Hydronidone and Entecavir, Tenofovir Disoproxil Fumarate, Tenofovir Alafenamide, and Tenofovir Amibufenamide

A Single-Center, Open-Label, Single-Arm, Self-Controlled Phase I Clinical Study to Evaluate Drug-Drug Interactions of Hydronidone With Entecavir, Tenofovir Disoproxil Fumarate, Tenofovir Alafenamide, and Tenofovir Amibufenamide in Healthy Chinese Subjects

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Beijing Continent Pharmaceutical Co, Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The proposed indication for Hydronidone Capsules is chronic hepatitis B-associated liver fibrosis, which in clinical practice typically requires concomitant use with antiviral agents for chronic hepatitis B. The commonly used chronic hepatitis B antiviral agents include Entecavir, Tenofovir Disoproxil Fumarate (TDF), Tenofovir Alafenamide (TAF), and Tenofovir Amibufenamide (TMF). This study aims to evaluate the drug-drug interaction (DDI) of Hydronidone Capsules 90 mg with Entecavir, Tenofovir Disoproxil Fumarate (TDF), Tenofovir Alafenamide (TAF), and Tenofovir Amibufenamide (TMF) respectively in healthy participants, to inform the preparation of post-marketing labeling and the development of concomitant dosing regimens in clinical practice.

Conditions

• Chronic Hepatitis B Liver Fibrosis
• DDI (Drug-Drug Interaction)

Interventions

Type	Name	Description
DRUG	Entecavir	0.5 mg, taken orally on an empty stomach, once a day
DRUG	Tenofovir Disoproxil Fumarate（TDF）	300 mg, taken orally on an empty stomach, once a day
DRUG	Tenofovir alafenamide（TAF）	25 mg, single oral dose, under fasting conditions
DRUG	Tenofovir Amibufenamide(TMF)	25 mg, single oral dose, under fasting conditions

Timeline

• Start date: 2025-12-30
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2025-12-22
• Last updated: 2025-12-22

Locations

1 site across 1 country: China