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A Multicenter, Open-label, Randomized, Multi-dose, 2-sequence, 2-period, Crossover Bioequivalence Study to Comparison of the Pharmacokinetics and Safety of DWZ2501 and DWC202510 in Patients with Advanced BRCA-mutated High-grade Ovarian Cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A (Olaparib, RT) | Experimental | Subjects are randomized into two sequence groups. In Sequence A, subjects receive R then T. T: DWZ2501(Olaparib) R: DW202510(Olaparib) |
|
| Sequence B (Olaparib, TR) | Experimental | Subjects are randomized into two sequence groups. In Sequence B, subjects receive T then R. T: DWZ2501(Olaparib) R: DW202510(Olaparib) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWZ2501 (Olaparib 150mg) | Drug | Subjects receive 600 mg per day, two tablets BID (total 4 tablets), oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum plasma concentration of olaparib | Day 8, Day 16 after dose administration |
| AUCtau | Area under the drug concentration-time curve of olapairb | Day 8, Day 16 after dose administration |
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Inclusion Criteria:
1. Female subjects aged 19 years or older at the time of obtaining written informed consent.
2. Patients with advanced high-grade ovarian cancer harboring a BRCA mutation. 3. Subjects who meet at least one of the following criteria:
Exclusion Criteria:
(1) Pneumonitis (2) Myelodysplastic syndrome or acute myeloid leukemia (3) Severe hepatic impairment(Child-Pugh class C). (4) Ongoing active infection or uncontrolled systemic disease (5) Active hepatitis B, hepatitis C, human immunodeficiency virus(HIV) infection, or syphilis.
3. Subjects who have received the following drug and non-drug treatments at screening:
5. Subjects who have experienced blood loss of approximately 350 mL or more within 12 weeks prior to screening.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institutional Review Board of Seoul National University Hospital | Recruiting | Seoul | Jongno-gu | 03080 | South Korea |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
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| ID | Term |
|---|---|
| C531550 | olaparib |
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| DWC202510 (Olaparib 150mg) | Drug | Subjects receive 600 mg per day, two tablets BID (total 4 tablets), oral administration |
|
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |