Drug-Drug Interaction and Food Effect of Sudapyridine(WX-081) With Itraconazole and Rifampin in Healthy Chinese Adults
Summary
The goal of this clinical trial is to learn how Sudapyridine (WX-081) tablets interact with other drugs and how food intake affects its pharmacokinetics in healthy Chinese adults. The main questions it aims to answer are: How does itraconazole (a strong CYP3A inhibitor) affect the pharmacokinetics of Sudapyridine? How does rifampin (a strong CYP3A inducer) affect the pharmacokinetics of Sudapyridine? How does food intake influence the pharmacokinetics of Sudapyridine? Participants will: Take Sudapyridine alone, with itraconazole, with rifampin, and under fed and fasting conditions based on a predefined sequence. Attend multiple clinic visits for blood sample collection and safety evaluations. Researchers will compare the pharmacokinetic parameters of Sudapyridine under these conditions to determine the impact of drug-drug interactions and food.
Timeline
- Start
- 2025-05-12
- Primary completion
- 2025-10-12
- Completion
- 2026-02-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Itraconazole | Small molecule | 200 mg | Oral |
| Subject | Rifampin | Small molecule | 600 mg | Oral |
| Subject | Sudapyridine | Small molecule | 300 mg | Oral |
| Subject | Sudapyridine | Small molecule | 450 mg | Oral |