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

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03156127
• Other study ID #: BR-UPS-CT-101
• Status: Withdrawn
• Phase: Phase 1
• First received: May 15, 2017
• Last updated: August 9, 2017
• Start date: May 19, 2017
• Est. completion date: October 2017

Study information

• Verified date: August 2017
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Withdrawn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

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Myoma

Intervention

Drug:
• BR-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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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