A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015-A and Co-administration of BR1015-3 and BR1015-2 Under Fasting Conditions

February 12, 2026 updated by: Boryung Pharmaceutical Co., Ltd

A Randomized, Open-label, Fasting, Oral Administration, Single Dose, 2-sequence, 4-period, Crossover Study to Evaluate the Pharmacokinetics and Safety After Administration of "BR1015-A" and Co-administration of "BR1015-3" and "BR1015-2" in Healthy Adult Volunteers

The purpose of this clinical trial is to evaluate the pharmacokinetics and the safety after administration of BR1015-A and co-administration of BR1015-3 and BR1015-2 in healthy volunteers under fasting conditions

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Subjects with a body mass index (BMI) of more than 18.0 kg/m² and less than 30.0 kg/m² at the screening visit.
  • Subjects who provide written informed consent voluntarily after receiving and understanding sufficient explanation regarding the purpose and procedures of the clinical trial, the characteristics of the investigational product, and the expected adverse events.
  • Subjects who agree to use a highly effective method of contraception, excluding hormonal contraceptives, from the time of signing the written informed consent form until 14 days after the last administration of the investigational product, and who agree not to donate sperm or ova during this period. This requirement applies to the subject and, as applicable, to their spouse or sexual partner in order to prevent pregnancy.

Exclusion Criteria:

  • Subjects who have taken drugs that induce or inhibit metabolizing enzymes, such as barbiturates, within 30 days prior to the first administration of the investigational product, or who have taken any prescription drugs, over-the-counter drugs (OTC), herbal medicines, or dietary supplements within 10 days prior to the first administration that may interfere with the conduct of the study (however, participation may be allowed considering the pharmacokinetics and pharmacodynamics, including potential interactions with the investigational product and the half-life of concomitant drugs).
  • Subjects with a medical history of gastrointestinal resection or gastrointestinal diseases that may affect the absorption of drugs (except for simple appendectomy or hernia surgery).
  • Subjects who have participated in other clinical trials (including bioequivalence studies) and received investigational products within 6 months prior to the first administration of this study. For this criterion, the 6-month period is counted from the last administration date of the investigational product in the previous study.
  • Subjects who are unable to discontinue consumption of foods that may affect the absorption, distribution, metabolism, or excretion of the investigational product (e.g., raw grapefruit, grapefruit juice, or foods containing grapefruit) from 48 hours prior to the first administration of the investigational product until the collection of the last pharmacokinetic blood sample.
  • Subjects who, for reasons other than those specified in the inclusion and exclusion criteria above, are judged by the principal investigator (or a sub-investigator delegated by the principal investigator) to be unsuitable for participation in the clinical trial.
  • Female subjects who are pregnant, suspected of being pregnant, or currently lactating.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BR1015-A
Drug: BR1015-A
One tablet administered alone
Active Comparator: BR1015-3+BR1015-2
Drug: BR1015-2
One tablet administered alone
Drug: BR1015-3
One tablet administered alone

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
AUCt of Fimasartan
Time Frame: From pre-dose (0 hour) through 48 hours post-dose in each period (Periods 1-4).
Area under the Plasma Concentration-Time Curve from Time Zero to Time t of Fimasartan
From pre-dose (0 hour) through 48 hours post-dose in each period (Periods 1-4).
AUCt of Indapamide
Time Frame: From pre-dose (0 hour) through 72 hours post-dose in each period (Periods 1-2).
Area under the Plasma Concentration-Time Curve from Time Zero to Time t of Indapamide
From pre-dose (0 hour) through 72 hours post-dose in each period (Periods 1-2).
Cmax of Fimasartan
Time Frame: From pre-dose (0 hour) through 48 hours post-dose in each period (Periods 1-4).
Maximum Concentration of Drug in Plasma of Fimasartan
From pre-dose (0 hour) through 48 hours post-dose in each period (Periods 1-4).
Cmax of Indapamide
Time Frame: From pre-dose (0 hour) through 72 hours post-dose in each period (Periods 1-2).
Maximum Concentration of Drug in Plasma of Indapamide
From pre-dose (0 hour) through 72 hours post-dose in each period (Periods 1-2).

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 13, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 11, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 11, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BR-FIC-CT-109

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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