A Clinical Trial Study to Evaluate the Pharmacokinetic Interaction and Safety Between BR1019-1 and BR1019-2 in Healthy Adult Subjects

September 26, 2023 updated by: Boryung Pharmaceutical Co., Ltd

A Randomized, Open-label, Multiple-dose, 6-sequence, 3-treatment, 3-period, Crossover Study to Evaluate the Pharmacokinetic Interaction and Safety Between BR1019-1 and BR1019-2 in Healthy Adult Subjects

The purpose of this study is to evaluate the pharmacokinetic interaction and safety between BR1019-1 and BR1019-2 in healthy adult subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy adults aged 19 to 55 years at screening
  • Those who voluntarily decide to participate in the study and provide written consent to follow the study directions after listening to and fully understanding the detailed explanation on this study

Exclusion Criteria:

  • Those who have clinically significant diseases associated with the cardiovascular system, respiratory system, liver, kidney, nervous system, endocrine system, blood/tumor, psychiatric disorders, or urinary system, as well as drug abuse, or a history thereof.
  • Those who took any prescription drugs or herbal medicines within 14 days prior to the first day of administration or any over-the-counter (OTC) drugs within 7 days prior to the first day of administration (however, if other conditions are appropriate according to the judgment of the investigator, they may participate in the clinical study.)
  • Those who took drugs inducing and inhibiting drug-metabolizing enzymes, such as barbiturates, within 30 days prior to the study initiation.
  • Those who have been on a diet (especially grapefruit juice or its products) that may affect the absorption, distribution, metabolism, and excretion of the drug within 7 days prior to the first day of administration.

  • Pregnant women, potentially pregnant women, or breast-feeding women Those who do not agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using medically acceptable methods of contraception* throughout the entire period from the date of the first administration of the investigational product to the end of the clinical study

    • Medically acceptable methods of contraception: Combined use of intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used
  • Those who are unwilling or unable to comply with the dietary and lifestyle guidelines required for the clinical study
  • Those who have clinically significant abnormalities in the results of other clinical laboratory tests or who have been determined by the investigator to be ineligible to participate in the clinical study due to other reasons (e.g., non-compliance with instructions, uncooperative attitude, etc.)

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: Sequence 1

The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3.

*sequence 1: A-B-C
Drug: BR1019-1
Treatment group A : One tablet of BR1019-1 administered alone once daily for 7 days.
Drug: BR1019-2
Treatment group B : One tablet of BR1019-2 administered alone once daily for 7 days.
Drug: BR1019-1 + BR1019-2
Treatment group C : One tablet each of BR1019-1 and BR1019-2 administered in combination once daily for 7 days.
Experimental: Sequence 2

The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3.

*sequence 2: A-C-B
Drug: BR1019-1
Treatment group A : One tablet of BR1019-1 administered alone once daily for 7 days.
Drug: BR1019-2
Treatment group B : One tablet of BR1019-2 administered alone once daily for 7 days.
Drug: BR1019-1 + BR1019-2
Treatment group C : One tablet each of BR1019-1 and BR1019-2 administered in combination once daily for 7 days.
Experimental: Sequence 3

The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3.

*sequence 3: B-A-C
Drug: BR1019-1
Treatment group A : One tablet of BR1019-1 administered alone once daily for 7 days.
Drug: BR1019-2
Treatment group B : One tablet of BR1019-2 administered alone once daily for 7 days.
Drug: BR1019-1 + BR1019-2
Treatment group C : One tablet each of BR1019-1 and BR1019-2 administered in combination once daily for 7 days.
Experimental: Sequence 4

The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3.

*sequence 4: B-C-A
Drug: BR1019-1
Treatment group A : One tablet of BR1019-1 administered alone once daily for 7 days.
Drug: BR1019-2
Treatment group B : One tablet of BR1019-2 administered alone once daily for 7 days.
Drug: BR1019-1 + BR1019-2
Treatment group C : One tablet each of BR1019-1 and BR1019-2 administered in combination once daily for 7 days.
Experimental: Sequence 5

The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3.

*sequence 5: C-A-B
Drug: BR1019-1
Treatment group A : One tablet of BR1019-1 administered alone once daily for 7 days.
Drug: BR1019-2
Treatment group B : One tablet of BR1019-2 administered alone once daily for 7 days.
Drug: BR1019-1 + BR1019-2
Treatment group C : One tablet each of BR1019-1 and BR1019-2 administered in combination once daily for 7 days.
Experimental: Sequence 6

The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3.

*sequence 6: C-B-A
Drug: BR1019-1
Treatment group A : One tablet of BR1019-1 administered alone once daily for 7 days.
Drug: BR1019-2
Treatment group B : One tablet of BR1019-2 administered alone once daily for 7 days.
Drug: BR1019-1 + BR1019-2
Treatment group C : One tablet each of BR1019-1 and BR1019-2 administered in combination once daily for 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC0-24,ss
Time Frame: 0-48 hours after administration
Area under the concentration-time curve from 0 h to 24 h of BR1019-1 and BR1019-2 at steady-state
0-48 hours after administration
Cmax,ss
Time Frame: 0-48 hours after administration
Maximum concentration of drug in plasma of BR1019-1 and BR1019-2 at steady-state
0-48 hours after administration

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 13, 2023

Primary Completion (Actual)

June 29, 2023

Study Completion (Actual)

June 29, 2023

Study Registration Dates

First Submitted

May 11, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR-FDC-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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