Relative Bioavailability Study of HR19042 in Healthy Subjects

Summary

This is a single-center, randomized, open-label, three-period, dual Latin square crossover study. Primary Objective： 1. To evaluate the oral relative bioavailability of HR19042 Capsules compared with budesonide delayed-release capsules (Tarpeyo®) and budesonide enteric-coated capsules (Budenofalk®). Secondary Objective 2. To assess safety following administration.

Timeline

Start

2023-12-27

Primary completion

2024-01-25

Completion

2024-01-25

Outcome

Met primary endpoint

release “结果显示， 本研究达到所有主要终点 ，HR19042胶囊可显著降低尿蛋白，并能有效延缓肾功能下降，且安全性与耐受性良好。” hengrui.com ↗

Publications

• Yin T, Zou J, Tang M, Yang M, Han Q, Jiang H, Hu H, Li X, Wu Y, Huang Y, He L. Comparison of the Pharmacokinetics of Three Budesonide Formulations in Healthy Chinese Subjects. Clin Pharmacol Drug Dev. 2026 Jan;15(1):e1603. doi: 10.1002/cpdd.1603. Epub 2025 Sep 12.

Drugs

Indications