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 range18 Years – 45 Years
SexALL
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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.
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.