Relative Bioavailability Study of HR19042 in Healthy Subjects (NCT06922305) | Clinical Trial Compass
CompletedPhase 1
Relative Bioavailability Study of HR19042 in Healthy Subjects
China18 participantsStarted 2023-12-27
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cmax: Maximum plasma concentration. Blood samples will be collected.
Timeframe: 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.
Timeframe: 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.
Timeframe: From Day 1 up to Day 8
4
Tmax: Observed time to reach Cmax. Blood samples will be collected.
. 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.