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This study aimed to evaluate the pharmacokinetic characteristics and bioequivalence of two olaparib tablets in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test-reference | Other | Administration order: The test olaparib tablets for 7 days, then the reference olaparib tablets for 7 days. |
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| Reference-test | Other | Administration order: The reference olaparib tablets for 7 days, then the test olaparib tablets for 7 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The test olaparib tablet (T) | Drug | The test olaparib tablet (Qilu Pharmaceutical Co., Ltd., Jinan, China) 300mg, every 12 hours |
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax,ss | The maximum plasma drug concentration at steady state | Day 7 |
| AUC0-τ | The area under the concentration-time curve between two dosings at steady state | 0-12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical College | Bengbu | Anhui | 233004 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| The reference olaparib tablet (R) | Drug | The reference olaparib tablet (Lynparza®; AstraZeneca PLC, Cambridge, England, UK) 300mg, every 12 hours |
|