Clinical trial · Interventional
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
NCT03156127CI-TRIAL-00029017withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Problem of Investigational Products
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Myoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BR-UPS 5 mg tablet, Inisia 5 mg tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BR-UPS 5 mg tablet
- interventionNames
- Drug: BR-UPS 5 mg tablet, Inisia 5 mg tablet
- type
- ACTIVE_COMPARATOR
- label
- Inisia 5 mg tablet
- interventionNames
- Drug: BR-UPS 5 mg tablet, Inisia 5 mg tablet
Primary outcomes (2)
- measure
- Cmax(Maximum concentration of drug in plasma) of Ulipristal Acetate
- timeFrame
- 0~120 hours after medication
- measure
- AUClast(Area under the plasma drug concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration) of Ulipristal Acetate
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.