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This is a single-center, randomized, open-label, three-period, dual Latin square crossover study.
Primary Objective:
To evaluate the oral relative bioavailability of HR19042 Capsules compared with budesonide delayed-release capsules (Tarpeyo®) and budesonide enteric-coated capsules (Budenofalk®).
Secondary Objective
To assess safety following administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Period 1: HR19042 Capsules Period 2: Tarpeyo® Period 3: Budenofalk® |
|
| Sequence 2 | Experimental | Period 1: Tarpeyo® Period 2: Budenofalk® Period 3: HR19042 Capsules |
|
| Sequence 3 | Experimental | Period 1: Budenofalk® Period 2: HR19042 Capsules Period 3: Tarpeyo® |
|
| Sequence 4 | Experimental | Period 1: Tarpeyo® Period 2: HR19042 Capsules Period 3: Budenofalk® |
|
| Sequence 5 | Experimental | Period 1: HR19042 Capsules Period 2: Budenofalk® Period 3: Tarpeyo® |
|
| Sequence 6 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum plasma concentration. Blood samples will be collected. | From Day 1 up to Day 8 | |
| 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. | From Day 1 up to Day 8 | |
| AUC0-∞: Area under the plasma concentration-time curve from time 0 to infinity. Blood samples will be collected. | From Day 1 up to Day 8 | |
| Tmax: Observed time to reach Cmax. Blood samples will be collected. | From Day 1 up to Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment emergent AEs (TEAEs) | From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 14) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Provincial People's Hospital | Chengdu | Sichuan | 610072 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40936477 | Derived | Yin T, Zou J, Tang M, Yang M, Han Q, Jiang H, Hu H, Li X, Wu Y, Huang Y, He L. Comparison of the Pharmacokinetics of Three Budesonide Formulations in Healthy Chinese Subjects. Clin Pharmacol Drug Dev. 2026 Jan;15(1):e1603. doi: 10.1002/cpdd.1603. Epub 2025 Sep 12. |
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| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| D019693 | Hepatitis, Autoimmune |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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Period 1: Budenofalk® Period 2: Tarpeyo® Period 3: HR19042 Capsules
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |