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Relative Bioavailability Study of HR19042 in Healthy Subjects

NCT06922305 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-04-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-27
Primary Completion
2024-01-25
Completion
2024-01-25

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06922305 on ClinicalTrials.gov