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.
Age range
18 Years – 50 Years
Sex
ALL
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Plasma hydronidone PK parameters of hydronidone capsules : steady-state peak concentration (Cmax,ss);
Timeframe: 23 days
Plasma hydronidone PK parametersof hydronidone capsules : Area under the plasma concentration-time curve from time zero to 24 hours at steady state (AUC0-24h,ss)
Timeframe: 23 days
Primary PK parameters of plasma of entecavir : AUC0-24h,ss.
Timeframe: 23 days
Primary PK parameters of plasma of entecavir : Cmax,ss .
Timeframe: 23 days
Primary PK parameters of plasma tenofovir alafenamide (TAF) : AUC0-24h,ss.
Timeframe: 23 days
Primary PK parameters of plasma tenofovir alafenamide (TAF) : Cmax,ss .
Timeframe: 23 days
Primary PK parameters of tenofovir disoproxil fumarate tablets (TDF): Cmax,ss .
Timeframe: 20 days
Primary PK parameters of tenofovir disoproxil fumarate tablets (TDF): AUC0-24h,ss.
Timeframe: 20 days
Primary PK parameters of plasma tenofovir amibufenamide (TMF) : Cmax,ss .
Timeframe: 23 days
Primary PK parameters of plasma tenofovir amibufenamide (TMF) : AUC0-24h,ss.
Timeframe: 23 days