Back to resultsA Study to Compare the Pharmacokinetics and Safety/Tolerability of BR-UPS (Ulipristal Acetate) 5 mg Tablet With Inisia (Ulipristal Acetate) 5 mg Tablet
Primary Purpose
Uterine Myoma
Status
Withdrawn
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
BR-UPS 5 mg tablet, Inisia 5 mg tablet
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Myoma
Eligibility Criteria
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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BR-UPS 5 mg tablet
Inisia 5 mg tablet
Arm Description
Outcomes
Primary Outcome Measures
Cmax(Maximum concentration of drug in plasma) of Ulipristal Acetate
AUClast(Area under the plasma drug concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration) of Ulipristal Acetate
Secondary Outcome Measures
Full Information
NCT ID
NCT03156127
First Posted
May 15, 2017
Last Updated
August 9, 2017
Sponsor
Boryung Pharmaceutical Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT03156127
Brief Title
A Study to Compare the Pharmacokinetics and Safety/Tolerability of BR-UPS (Ulipristal Acetate) 5 mg Tablet With Inisia (Ulipristal Acetate) 5 mg Tablet
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Problem of Investigational Products
Study Start Date
May 19, 2017 (Actual)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boryung Pharmaceutical Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Myoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BR-UPS 5 mg tablet
Arm Type
Experimental
Arm Title
Inisia 5 mg tablet
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
BR-UPS 5 mg tablet, Inisia 5 mg tablet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cmax(Maximum concentration of drug in plasma) of Ulipristal Acetate
Time Frame
0~120 hours after medication
Title
AUClast(Area under the plasma drug concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration) of Ulipristal Acetate
Time Frame
0~120 hours after medication
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Compare the Pharmacokinetics and Safety/Tolerability of BR-UPS (Ulipristal Acetate) 5 mg Tablet With Inisia (Ulipristal Acetate) 5 mg Tablet
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