Drug-Drug Interaction Study Between Hydronidone and Entecavir, Tenofovir Disoproxil Fumarate, Tenofovir Alafenamide, and Tenofovir Amibufenamide
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.
Timeline
- Start
- 2025-12-30
- Primary completion
- 2026-06-30
- Completion
- 2026-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Entecavir | Small molecule | 0.5 mg | Oral |
| Subject | Tenofovir Amibufenamide | Unknown | 25 mg | Oral |
| Subject | Tenofovir disoproxil fumarate | Small molecule | 300 mg | Oral |
| Subject | tenofovir alafenamide | Small molecule | 25 mg | Oral |