Study Stopped
Problem of Investigational Products
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
1 other identifier
interventional
N/A
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2017
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2017
CompletedFirst Posted
Study publicly available on registry
May 17, 2017
CompletedStudy Start
First participant enrolled
May 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedAugust 10, 2017
August 1, 2017
1 month
May 15, 2017
August 9, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
BR-UPS 5 mg tablet
EXPERIMENTALInisia 5 mg tablet
ACTIVE COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2017
First Posted
May 17, 2017
Study Start
May 19, 2017
Primary Completion
July 1, 2017
Study Completion
October 1, 2017
Last Updated
August 10, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share