A Study to Compare the Pharmacokinetics and Safety/Tolerability of BR-UPS (Ulipristal Acetate) 5 mg Tablet With Inisia (Ulipristal Acetate) 5 mg Tablet

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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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

Conditions
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Uterine Myoma

Intervention / Treatment
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* Drug: BR-UPS 5 mg tablet, Inisia 5 mg tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A subject provide written informed consent which he voluntarily confirms willingness to participate in a study, having been informed of the full details of the study and comply with the protocol. A Healthy female volunteers, aged 19-45 years BMI 18   27(kg/m2) Exclusion Criteria: History or presence of clinically significant medical or psychiatric condition or disease. History of gastrointestinal disease and resection History of clinically significant hypersensitivity to study drug, any other drug A subject with clinically significant genital bleeding Participation in any other study within 3 months Positive results for urine β-hCG in screening or lactating women A subject is using a method of hormone contraception and a Progesterone intrauterine device

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BR-UPS 5 mg tablet<br> | Drug: BR-UPS 5 mg tablet, Inisia 5 mg tablet<br>* 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.<br>|
| Active Comparator: Inisia 5 mg tablet<br> | Drug: BR-UPS 5 mg tablet, Inisia 5 mg tablet<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |