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

Status and phase

Withdrawn

Phase 1

Conditions

Uterine Myoma

Treatments

Drug: BR-UPS 5 mg tablet, Inisia 5 mg tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT03156127

BR-UPS-CT-101

Details and patient eligibility

About

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

Full 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

Sex

Female

Ages

19 to 45 years old

Volunteers

Accepts Healthy Volunteers

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