Uterine Myoma Clinical Trial
Official title:
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
Verified date | August 2017 |
Source | Boryung Pharmaceutical Co., Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 2017 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 19 Years to 45 Years |
Eligibility |
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 ß-hCG in screening or lactating women - A subject is using a method of hormone contraception and a Progesterone intrauterine device |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Boryung Pharmaceutical Co., Ltd |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cmax(Maximum concentration of drug in plasma) of Ulipristal Acetate | 0~120 hours after medication | ||
Primary | 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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