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

NCT07421375 | Not Yet Recruiting Phase 1

• 1 other identifier: BR-FIC-CT-107
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief 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 fasting conditions

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (4)

• AUCt of Fimasartan

  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

  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

  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

  Maximum Concentration of Drug in Plasma of Indapamide

  From pre-dose (0 hour) through 72 hours post-dose in each period (Periods 1-2).

Study Arms (2)

BR1015-A

EXPERIMENTAL

Drug: BR1015-A

BR1015-1+BR1015-2

ACTIVE COMPARATOR

Drug: BR1015-1; Drug: BR1015-2

Interventions

BR1015-A DRUG

One tablet administered alone

BR1015-A

BR1015-1 DRUG

One tablet administered alone

BR1015-1+BR1015-2

BR1015-2 DRUG

One tablet administered alone

BR1015-1+BR1015-2

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Soo Hee Kim

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: April 2, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02