A Study to Compare the Pharmacokinetics and Safety/Tolerability of BR-UPS (Ulipristal Acetate) 5 mg Tablet With Inisia (Ulipristal Acetate) 5 mg Tablet
Phase 1
Withdrawn
- Conditions
- Uterine Myoma
- Interventions
- Drug: BR-UPS 5 mg tablet, Inisia 5 mg tablet
- Registration Number
- NCT03156127
- Lead Sponsor
- Boryung Pharmaceutical Co., Ltd
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description BR-UPS 5 mg tablet BR-UPS 5 mg tablet, Inisia 5 mg tablet - Inisia 5 mg tablet BR-UPS 5 mg tablet, Inisia 5 mg tablet -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of