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

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

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03156127

Enrollment

Registered

2017-05-17

Start date

2017-05-19

Completion date

2017-10-31

Last updated

2017-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Myoma

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

Interventions

DRUGBR-UPS 5 mg tablet, Inisia 5 mg tablet

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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

19 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026