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Problem of Investigational Products
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The purpose of this study is to evaluate the Pharmacokinetics and Safety / Tolerability of BR-UPS (Ulipristal acetate) 5 mg tablet with Inisia (Ulipristal acetate) 5 mg tablet in healthy female volunteers
This is a randomized, open-label, single dose, two-way crossover study to compare the pharmacokinetics and safety/tolerability of BR-UPS (Ulipristal acetate) 5 mg tablet with Inisia (Ulipristal acetate) 5 mg tablet in healthy female volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BR-UPS 5 mg tablet | Experimental |
| |
| Inisia 5 mg tablet | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BR-UPS 5 mg tablet, Inisia 5 mg tablet | Drug | Subjects of Control group will be first orally administered with inisia 5mg tablet . After washout period of 2 weeks, They will be orally administered with BR-UPS 5mg tablet. On the contrary, Subjects of Test group will be first orally administered with BR-UPS 5mg tablet. After washout period of 2 weeks, They will be orally administered with inisia 5mg tablet. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax(Maximum concentration of drug in plasma) of Ulipristal Acetate | 0~120 hours after medication | |
| AUClast(Area under the plasma drug concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration) of Ulipristal Acetate | 0~120 hours after medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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|
| ID | Term |
|---|---|
| D047708 | Myofibroma |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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