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OpenTrials
Completed

NCT Number: NCT06922305

Relative Bioavailability Study of HR19042 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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Subject with any history of severe allergic or anaphylactic reactions to any allergen including drugs, or allergic disease diagnosed and treated by a physician.
  • 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
  • Subject has positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or treponema pallidum antibody.
  • History of any gastrointestinal surgery or cholecystectomy that could impact the PK of study drugs.
  • Participated in other clinical trials within 3 months before screening or plan to participate in other clinical trials during this study.
  • Blood loss or blood donation of more than 300 mL within 3 months before screening, or intended to donate blood during the trial.
  • Those who have been vaccinated with vaccines within 3 month before screening or who have an intention to vaccinate during the trial.
  • Difficulty in venous blood sampling or fear of needles/blood.
  • Difficulty in swallowing capsules, or inability to comply with the provided diet and study-related instructions.

Treatment and study plan

HR19042 Capsule, Tarpeyo®, Budenofalk®

Drug

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

Primary outcomes

  1. Cmax: Maximum plasma concentration. Blood samples will be collected.

    Time frame: From Day 1 up to Day 8

  2. 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

  3. 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

  4. Tmax: Observed time to reach Cmax. Blood samples will be collected.

    Time frame: From Day 1 up to Day 8

Secondary outcomes

  1. Incidence of treatment emergent AEs (TEAEs)

    Time frame: From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 14)

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 10, 2025
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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