MedTrace Logo

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

NCT03156127 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2017-08-10

No results posted yet for this study

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

Conditions

  • Uterine Myoma

Interventions

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.

Sponsors & Collaborators

  • Boryung Pharmaceutical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-19
Primary Completion
2017-07-31
Completion
2017-10-31

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03156127 on ClinicalTrials.gov