NCT06922305

Relative Bioavailability Study of HR19042 in Healthy Subjects

A Study on the Relative Bioavailability of HR19042 Capsules in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Primary IgA Nephropathy; Autoimmune Hepatitis

Interventions

Type	Name	Description
DRUG	HR19042 Capsule, Tarpeyo®, Budenofalk®	In each period under fasting conditions, subjects received oral administration of either HR19042 Capsule 16 mg, Tarpeyo® 16 mg, or Budenofalk® 15 mg.

Timeline

• Start date: 2023-12-27
• Primary completion: 2024-01-25
• Completion: 2024-01-25
• First posted: 2025-04-10
• Last updated: 2025-04-22

Locations

1 site across 1 country: China