Who is sponsoring NCT03156127?

NCT03156127 is sponsored by Boryung Pharmaceutical Co., Ltd.

What condition does NCT03156127 study?

NCT03156127 studies Uterine Myoma.

What drugs are being tested in NCT03156127?

Interventions: BR-UPS 5 mg tablet, Inisia 5 mg tablet.

What is the status of NCT03156127?

NCT03156127 is currently WITHDRAWN.

Last reviewed 2017-08-09 · How we verify

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

NCT03156127 Phase 1 WITHDRAWN

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

Details

Lead sponsor	Boryung Pharmaceutical Co., Ltd
Phase	Phase 1
Status	WITHDRAWN
Start date	2017-05-19
Completion	2017-10

Conditions

Uterine Myoma

Interventions

BR-UPS 5 mg tablet, Inisia 5 mg tablet

Primary outcomes

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