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A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015-A and Co-administration of BR1015-1 and BR1015-2 Under Fed Conditions | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1

A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015-A and Co-administration of BR1015-1 and BR1015-2 Under Fed Conditions

A Randomized, Open-label, Fed, 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 "BR1015-1" and "BR1015-2" in Healthy Adult Volunteers

NCT07421388•Boryung Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

Summary

The purpose of this clinical trial is to evaluate the pharmacokinetics and the safety after administration of BR1015-A and co-administration of BR1015-1 and BR1015-2 in healthy volunteers under fed conditions

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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.
•Female subjects who are pregnant, suspected of being pregnant, or currently lactating.

Key Dates

Start Date

April 9, 2026

Primary Completion Date

June 7, 2026

Completion Date

June 7, 2026

Last Updated

February 19, 2026

Enrollment

ESTIMATED participants

Conditions

Essential Hypertension

Interventions

BR1015-A

DRUG

BR1015-1

DRUG

BR1015-2

DRUG

Contacts

Soo Hee Kim

CONTACT

02-708-8000 shkim0127@boryung.co.kr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015-A and Co-administration of BR1015-1 and BR1015-2 Under Fed Conditions

Inclusion Criteria

Exclusion Criteria

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