Drug-Drug Interaction and Food Effect of Sudapyridine(WX-081) With Itraconazole and Rifampin in Healthy Chinese Adults

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.

NCT Number	NCT06701136
Lead Sponsor	Shanghai Jiatan Pharmatech Co., Ltd
Conditions	Rifampicin-Resistant Pulmonary Tuberculosis Patients
Enrollment	16 participants
Start Date	2025-05-12
Primary Completion	2025-10-12 (estimated)
Study Completion	2026-02-12 (estimated)
Updated on ClinicalTrials.gov	2025-02-12