Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is being conducted to evaluate the effect of high-fat meal on pharmacokinetics of SHR7280 after oral administration and the effect of SHR7280 on QT interval at low and high doses in healthy Chinese volunteers.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental |
| |
| Treatment group B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR7280 Tablet | Drug | Oral SHR7280 tablet. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Peak concentration (Cmax) | Day 1 to Day 8. | |
| Area under the plasma concentration-time curve from time 0 to the last quantifiable timepoint (AUC0-t) | Day 1 to Day 8. | |
| Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞) | Day 1 to Day 8. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to peak concentration (Tmax) | Day 1 to Day 8. | |
| Elimination half-life (t1/2) | Day 1 to Day 8. | |
| Adverse events (AEs) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510300 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| SHR7280 Placebo Tablet |
| Drug |
Oral SHR7280 placebo tablet. |
|
| Day 1 to Day 15. |
| D000091662 | Genital Diseases |
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |