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Drug-Drug Interaction and Food Effect of Sudapyridine(WX-081) With Itraconazole and Rifampin in Healthy Chinese Adults
Sponsor: Shanghai Jiatan Pharmatech Co., Ltd
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.
Official title: A Clinical Study to Evaluate the Drug-Drug Interaction and Food Effect of Sudapyridine(WX-081) Tablet With Itraconazole and Rifampin in Healthy Chinese Adult Volunteers
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
16
Start Date
2025-05-12
Completion Date
2026-02-12
Last Updated
2025-02-12
Healthy Volunteers
Yes
Interventions
Sudapyridine
In Study A, Cycle 1 (D1-D10): Participants will take Sudapyridine (WX-081) 300 mg once daily after breakfast. Cycle 2 (D11-D14): Participants will take Sudapyridine 300 mg once daily after breakfast with itraconazole 200 mg daily; an additional itraconazole dose (200 mg) will be given after dinner on D11. In Study B, Cycle 1 (D1): Participants will take Sudapyridine 450 mg as a single dose after breakfast. Cycle 2 (D22): Participants will take Sudapyridine 450 mg with rifampin 600 mg daily (D15-D27). In Study C, Cycle 1 (D1): Sudapyridine 450 mg will be given fasting; Cycle 2 (D15): after a high-fat breakfast.
Itraconazole
In Study A: Participants will receive itraconazole capsules at 200 mg orally once daily after breakfast during Cycle 2 (D11-D14). An additional dose of itraconazole (200 mg) will be administered after dinner on D11.
Rifampin
In Study B: Participants will receive rifampin capsules at 600 mg orally once daily under fasting conditions during Cycle 2 (D15-D27).