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NOT YET RECRUITING
NCT07295873
PHASE1

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

Sponsor: Beijing Continent Pharmaceutical Co, Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2025-12-30

Completion Date

2026-06-30

Last Updated

2025-12-22

Healthy Volunteers

Yes

Interventions

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

Locations (1)

Beijing Gaobo Hospital

Beijing, China