NCT06922305CompletedPhase 1
Relative Bioavailability Study of HR19042 in Healthy Subjects
A Study on the Relative Bioavailability of HR19042 Capsules in Healthy Subjects
Source: ClinicalTrials.gov · Last updated 22 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- First submitted
- 3 Apr 2025
- Start date
- 27 Dec 2023
- Primary completion date
- 25 Jan 2024
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Diseases
- IgA nephropathy
- NCT number
- NCT06922305
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 18
- From 27 Dec 2023 to the primary completion date, 25 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sichuan Provincial People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.