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Not yet recruitingNCT07421401Updated Feb 19, 2026

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

A Phase 1 interventional study of BR1015-A and BR1015-3 in Essential Hypertension, sponsored by Boryung Pharmaceutical Co., Ltd. Not yet recruiting. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-19.

Sponsored by Boryung Pharmaceutical Co., Ltd · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Essential Hypertension
03

In context

Essential Hypertension

478 studies on the registry are indexed under Essential Hypertension; 74 are open to participants now.

This study's planned enrollment of 58 is below the median of 144 across 406 interventional studies indexed under Essential Hypertension.

Browse Essential Hypertension studies →

Lead sponsor

Boryung Pharmaceutical Co., Ltd is the lead sponsor of 143 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects with a (BMI) of more than 18.0 kg/m² and less than 30.0 kg/m² at the screening visit.
  • Subjects who provide written voluntarily after receiving and understanding sufficient explanation regarding the purpose and procedures of the clinical trial, the characteristics of the product, and the expected adverse events.
  • Subjects who agree to use a highly effective method of , 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

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 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
58 participants (estimated)

Study arms

  • Experimental
    BR1015-A

    Drug: BR1015-A

  • Active comparator
    BR1015-3+BR1015-2

    Drug: BR1015-3 · Drug: BR1015-2

Interventions

  • One tablet administered alone

  • DrugBR1015-3

    One tablet administered alone

  • One tablet administered alone

06

What researchers measure

Primary outcomes

  1. AUCt of Fimasartan

    Area under the Plasma Concentration-Time Curve from Time Zero to Time t of Fimasartan

    Time frame: From pre-dose (0 hour) through 48 hours post-dose in each period (Periods 1-4).

  2. AUCt of Indapamide

    Area under the Plasma Concentration-Time Curve from Time Zero to Time t of Indapamide

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

  3. Cmax of Fimasartan

    Maximum Concentration of Drug in Plasma of Fimasartan

    Time frame: From pre-dose (0 hour) through 48 hours post-dose in each period (Periods 1-4).

  4. Cmax of Indapamide

    Maximum Concentration of Drug in Plasma of Indapamide

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07421401
Responsible party
Sponsor
First posted
Feb 19, 2026
Start date
Apr 13, 2026 (estimated)
Primary completion
Jun 11, 2026 (estimated)
Completion
Jun 11, 2026 (estimated)
Last update
Feb 19, 2026

Study contacts

Soo Hee Kim
Contact
shkim0127@boryung.co.kr
02-708-8000

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: BR1015

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