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The primary objective of this study is to evaluate the effect of food on the pharmacokinetics of HS-10518
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence AB | Experimental | fasting, fed |
|
| Sequence BA | Experimental | fed, fasting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-10518 | Drug | Treatment A: Single oral dose of HS-10518 160 mg tablet under fasted conditions Treatment B: Single oral dose of HS-10518 160 mg tablet after a high-fat meal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cmax) of HS-10518 | predose and within 48 hours postdose in each treatment period | |
| Area under the plasma concentration versus time curve (AUC0-t) of HS-10518 | within 48 hours postdose in each treatment period | within 48 hours postdose in each treatment period |
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Inclusion Criteria:
Exclusion Criteria:
Premenopausal adult female subjects
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| D000091662 | Genital Diseases |