Relative Bioavailability Study of HR19042 in Healthy Subjects

April 21, 2025 updated by: Jiangsu HengRui Medicine Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Sichuan Provincial People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Male or female subjects, ages 18 to 45, inclusive, at the time of informed consent.
  2. Female subjects weigh ≥ 45 kg, male subjects weigh ≥ 50 kg, and BMI between 19.0 and 28.0 kg/m2, inclusive, at screening.
  3. Understands the study procedures in the informed consent form ICF and be willing and able to comply with the protocol.

Exclusion Criteria:

  1. Subject with any history of severe allergic or anaphylactic reactions to any allergen including drugs, or allergic disease diagnosed and treated by a physician.
  2. Clinically significant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine or connective tissue diseases or disorders
  3. Subject has positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or treponema pallidum antibody.
  4. History of any gastrointestinal surgery or cholecystectomy that could impact the PK of study drugs.
  5. Participated in other clinical trials within 3 months before screening or plan to participate in other clinical trials during this study.
  6. Blood loss or blood donation of more than 300 mL within 3 months before screening, or intended to donate blood during the trial.
  7. Those who have been vaccinated with vaccines within 3 month before screening or who have an intention to vaccinate during the trial.
  8. Difficulty in venous blood sampling or fear of needles/blood.
  9. Difficulty in swallowing capsules, or inability to comply with the provided diet and study-related instructions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence 1
Period 1: HR19042 Capsules Period 2: Tarpeyo® Period 3: Budenofalk®
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.
Experimental: Sequence 2
Period 1: Tarpeyo® Period 2: Budenofalk® Period 3: HR19042 Capsules
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.
Experimental: Sequence 3
Period 1: Budenofalk® Period 2: HR19042 Capsules Period 3: Tarpeyo®
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.
Experimental: Sequence 4
Period 1: Tarpeyo® Period 2: HR19042 Capsules Period 3: Budenofalk®
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.
Experimental: Sequence 5
Period 1: HR19042 Capsules Period 2: Budenofalk® Period 3: Tarpeyo®
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.
Experimental: Sequence 6
Period 1: Budenofalk® Period 2: Tarpeyo® Period 3: HR19042 Capsules
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax: Maximum plasma concentration. Blood samples will be collected.
Time Frame: From Day 1 up to Day 8
From Day 1 up to Day 8
AUC0-t: Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration. Blood samples will be collected.
Time Frame: From Day 1 up to Day 8
From Day 1 up to Day 8
AUC0-∞: Area under the plasma concentration-time curve from time 0 to infinity. Blood samples will be collected.
Time Frame: From Day 1 up to Day 8
From Day 1 up to Day 8
Tmax: Observed time to reach Cmax. Blood samples will be collected.
Time Frame: From Day 1 up to Day 8
From Day 1 up to Day 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of treatment emergent AEs (TEAEs)
Time Frame: From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 14)
From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 14)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2023

Primary Completion (Actual)

January 25, 2024

Study Completion (Actual)

January 25, 2024

Study Registration Dates

First Submitted

April 3, 2025

First Submitted That Met QC Criteria

April 3, 2025

First Posted (Actual)

April 10, 2025

Study Record Updates

Last Update Posted (Actual)

April 22, 2025

Last Update Submitted That Met QC Criteria

April 21, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HR19042-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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