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.
Be fully informed about the trial and demonstrate understanding of its content, procedures, and potential adverse events related to the investigational product; voluntarily provide written informed consent; and be able to comply with all study procedures and complete the study in accordance with the protocol requirements.
Male or female subjects aged 18 to 50 years, inclusive, at the time of signing informed consent.
At screening, male subjects must weigh ≥50.0 kg and female subjects must weigh ≥45.0 kg, with a body mass index (BMI) between 19.0 and 26.0 kg/m², inclusive.
At screening, all laboratory tests and related examinations (including vital signs, physical examination, 12-lead ECG, chest X-ray [PA view], abdominal ultrasound, etc.) must be within normal range or, if abnormal, determined by the investigator to be not clinically significant.
Presence of any clinically significant disease or medical history that, in the opinion of the investigator, may interfere with protocol compliance or completion of the study, including but not limited to abnormalities of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematologic system, immune system, psychiatric system, or endocrine/metabolic system.
Positive results for any infectious disease screening tests at screening, including hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), human immunodeficiency virus antigen/antibody (HIV Ag/Ab), or Treponema pallidum antibody (TP Ab).
History of drug or food allergies, or known hypersensitivity to the active pharmaceutical ingredients of the investigational medicinal products (hydronidone, entecavir, tenofovir disoproxil fumarate, tenofovir alafenamide, tenofovir amibufenamide) or to any of their excipients.
Participants with rare genetic disorders of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption;
Single group
Entecavir
Drug0.5 mg, taken orally on an empty stomach, once a day
Tenofovir Disoproxil Fumarate（TDF）
Drug300 mg, taken orally on an empty stomach, once a day
Tenofovir alafenamide（TAF）
Drug25 mg, single oral dose, under fasting conditions
Tenofovir Amibufenamide(TMF)
Drug25 mg, single oral dose, under fasting conditions
Plasma hydronidone PK parameters of hydronidone capsules : steady-state peak concentration (Cmax,ss);
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)
Primary PK parameters of plasma of entecavir : AUC0-24h,ss.
Primary PK parameters of plasma of entecavir : Cmax,ss .
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