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

Boryung Pharmaceutical Co., Ltd

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Uterine Myoma

Interventions

BR-UPS 5 mg tablet, Inisia 5 mg tabletDRUG

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.

Eligibility

Sex: FEMALEMin age: 19 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Cmax(Maximum concentration of drug in plasma) of Ulipristal Acetate

Time frame: 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

Time frame: 0~120 hours after medication

Data from ClinicalTrials.gov

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