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

Sponsor

Boryung Pharmaceutical Co., Ltd (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT03156127

Collaborator

(none)

Enrollment

Location

Arms

4.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Uterine Myoma	Drug: BR-UPS 5 mg tablet, Inisia 5 mg tablet	Phase 1

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

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 19, 2017

Anticipated Primary Completion Date :

Jul 1, 2017

Anticipated Study Completion Date :

Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BR-UPS 5 mg tablet	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.
Active Comparator: Inisia 5 mg tablet	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.

Arm

Intervention/Treatment

Experimental: BR-UPS 5 mg tablet

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.

Active Comparator: Inisia 5 mg tablet

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Boryung Pharmaceutical Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Boryung Pharmaceutical Co., Ltd

ClinicalTrials.gov Identifier:

NCT03156127

Other Study ID Numbers:

BR-UPS-CT-101

First Posted:

May 17, 2017

Last Update Posted:

Aug 10, 2017

Last Verified:

Aug 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Leiomyoma

Myofibroma

Study Results

No Results Posted as of Aug 10, 2017