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To assess the relative bioavailability of SHR7280 dry suspension and tablets in healthy subjects.
To assess the safety and tolerability of a single dose of SHR7280 dry suspension and tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group ARM 1 | Experimental | SHR7280 dry suspension then SHR7280 tablets |
|
| Treatment group ARM 2 | Experimental | SHR7280 tablets, then SHR7280 dry suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR7280 tablets | Drug | SHR7280 tablets 1 time |
| |
| Measure | Description | Time Frame |
|---|---|---|
| SHR7280 and its main Pk parameter AUC0-t | Day 1 to Day 5 | |
| SHR7280 and its main Pk parameter AUC0-∞ | Day 1 to Day 5 | |
| SHR7280 and its main Pk parameter Cmax | Day 1 to Day 5 | |
| Relative bioavailability (F%) value between SHR7280 dry suspension and SHR7280 tablet: F% = AUC0-t (dry suspension) / AUC0-t (tablet) ×100% | Day 1 to Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| SHR7280 and its main Pk parameter Tmax (SHR7280 only) | Day 1 to Day 5 | |
| SHR7280 and its main Pk parameter t1/2 (SHR7280 only) | Day 1 to Day 5 | |
| SHR7280 and its main Pk parameter CL/F (SHR7280 only) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 511447 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40779283 | Derived | Liu X, Qin R, Shu C, Shen K, Li X, Ma L, Li X, Li L, Peng J, Huang D, Chen S, Xie Z, Ye L, Duan L. Relative Bioavailability of Single-Dose Oral Administration of Two SHR7280 Formulations (Dry Suspension and Tablets) in Healthy Chinese Volunteers. Clin Drug Investig. 2025 Sep;45(9):643-650. doi: 10.1007/s40261-025-01470-7. Epub 2025 Aug 8. |
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| SHR7280 dry suspension |
| Drug |
SHR7280 dry suspension 1 time |
|
| Day 1 to Day 5 |
| SHR7280 and its main Pk parameter Vz/F (SHR7280 only) | Day 1 to Day 5 |
| Adverse events | Day 1 to Day 10 |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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