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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 27, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 25, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 25, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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