Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT06922305
Status:
COMPLETED
Last Update Posted:
2025-04-22
First Post:
2025-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relative Bioavailability Study of HR19042 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005922', 'term': 'Glomerulonephritis, IGA'}, {'id': 'D019693', 'term': 'Hepatitis, Autoimmune'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019819', 'term': 'Budesonide'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-21', 'studyFirstSubmitDate': '2025-04-03', 'studyFirstSubmitQcDate': '2025-04-03', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax: Maximum plasma concentration. Blood samples will be collected.', 'timeFrame': 'From Day 1 up to Day 8'}, {'measure': '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'}, {'measure': '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'}, {'measure': 'Tmax: Observed time to reach Cmax. Blood samples will be collected.', 'timeFrame': 'From Day 1 up to Day 8'}], 'secondaryOutcomes': [{'measure': 'Incidence of treatment emergent AEs (TEAEs)', 'timeFrame': 'From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 14)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary IgA Nephropathy; Autoimmune Hepatitis']}, 'descriptionModule': {'briefSummary': 'This is a single-center, randomized, open-label, three-period, dual Latin square crossover study.\n\nPrimary Objective：\n\n1. To evaluate the oral relative bioavailability of HR19042 Capsules compared with budesonide delayed-release capsules (Tarpeyo®) and budesonide enteric-coated capsules (Budenofalk®).\n\n Secondary Objective\n2. To assess safety following administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female subjects, ages 18 to 45, inclusive, at the time of informed consent.\n2. Female subjects weigh ≥ 45 kg, male subjects weigh ≥ 50 kg, and BMI between 19.0 and 28.0 kg/m2, inclusive, at screening.\n3. Understands the study procedures in the informed consent form ICF and be willing and able to comply with the protocol.\n\nExclusion Criteria:\n\n1. Subject with any history of severe allergic or anaphylactic reactions to any allergen including drugs, or allergic disease diagnosed and treated by a physician.\n2. 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\n3. Subject has positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or treponema pallidum antibody.\n4. History of any gastrointestinal surgery or cholecystectomy that could impact the PK of study drugs.\n5. Participated in other clinical trials within 3 months before screening or plan to participate in other clinical trials during this study.\n6. Blood loss or blood donation of more than 300 mL within 3 months before screening, or intended to donate blood during the trial.\n7. Those who have been vaccinated with vaccines within 3 month before screening or who have an intention to vaccinate during the trial.\n8. Difficulty in venous blood sampling or fear of needles/blood.\n9. Difficulty in swallowing capsules, or inability to comply with the provided diet and study-related instructions.'}, 'identificationModule': {'nctId': 'NCT06922305', 'briefTitle': 'Relative Bioavailability Study of HR19042 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Study on the Relative Bioavailability of HR19042 Capsules in Healthy Subjects', 'orgStudyIdInfo': {'id': 'HR19042-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence 1', 'description': 'Period 1: HR19042 Capsules Period 2: Tarpeyo® Period 3: Budenofalk®', 'interventionNames': ['Drug: HR19042 Capsule, Tarpeyo®, Budenofalk®']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2', 'description': 'Period 1: Tarpeyo® Period 2: Budenofalk® Period 3: HR19042 Capsules', 'interventionNames': ['Drug: HR19042 Capsule, Tarpeyo®, Budenofalk®']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 3', 'description': 'Period 1: Budenofalk® Period 2: HR19042 Capsules Period 3: Tarpeyo®', 'interventionNames': ['Drug: HR19042 Capsule, Tarpeyo®, Budenofalk®']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 4', 'description': 'Period 1: Tarpeyo® Period 2: HR19042 Capsules Period 3: Budenofalk®', 'interventionNames': ['Drug: HR19042 Capsule, Tarpeyo®, Budenofalk®']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 5', 'description': 'Period 1: HR19042 Capsules Period 2: Budenofalk® Period 3: Tarpeyo®', 'interventionNames': ['Drug: HR19042 Capsule, Tarpeyo®, Budenofalk®']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 6', 'description': 'Period 1: Budenofalk® Period 2: Tarpeyo® Period 3: HR19042 Capsules', 'interventionNames': ['Drug: HR19042 Capsule, Tarpeyo®, Budenofalk®']}], 'interventions': [{'name': 'HR19042 Capsule, Tarpeyo®, Budenofalk®', 'type': 'DRUG', 'description': 'In each period under fasting conditions, subjects received oral administration of either HR19042 Capsule 16 mg, Tarpeyo® 16 mg, or Budenofalk® 15 mg.', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4', 'Sequence 5', 'Sequence 6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610072', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': "Sichuan Provincial People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}