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

August 9, 2017 updated by: Boryung Pharmaceutical Co., Ltd

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax(Maximum concentration of drug in plasma) of Ulipristal Acetate
Time Frame: 0~120 hours after medication
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
Time Frame: 0~120 hours after medication
0~120 hours after medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boryung Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2017

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

May 15, 2017

First Submitted That Met QC Criteria

May 15, 2017

First Posted (Actual)

May 17, 2017

Study Record Updates

Last Update Posted (Actual)

August 10, 2017

Last Update Submitted That Met QC Criteria

August 9, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR-UPS-CT-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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