Essential HypertensionPhase 1NCT07421388
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 Phase 1 study testing BR1015-A, BR1015-1 and BR1015-2 in people with Essential Hypertension, run by Boryung Pharmaceutical Co., Ltd.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- BR1015-A, BR1015-1 and BR1015-2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 9 Apr 2026to 7 Jun 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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
- Conditions
- Essential Hypertension
- Being tested
- BR1015-A, BR1015-1, BR1015-2
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BR1015-ADrug
One tablet administered alone
BR1015-1Drug
One tablet administered alone
BR1015-2Drug
One tablet administered alone
| Study group | Role | What they receive |
|---|---|---|
| BR1015-A | Experimental | Not described Receives: Drug: BR1015-A |
| BR1015-1+BR1015-2 | Active comparator | Not described Receives: Drug: BR1015-1; Drug: BR1015-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of Fimasartan
Area under the Plasma Concentration-Time Curve from Time Zero to Time t of Fimasartan
Measured: 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
Measured: 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
Measured: 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
Measured: From pre-dose (0 hour) through 72 hours post-dose in each period (Periods 1-2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start9 Apr 2026 (estimated)
- Primary completion7 Jun 2026 (estimated)
- Study completion7 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421388
- Sponsor's protocol ID
- BR-FIC-CT-108
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07421388
- Acronym / sponsor ID
- BR-FIC-CT-108
- Conditions
- Essential Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2026 (estimated)
- Primary completion
- 7 Jun 2026 (estimated)
- Study completion
- 7 Jun 2026 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BR1015-A | Experimental | Drug: BR1015-A |
| BR1015-1+BR1015-2 | Active comparator | Drug: BR1015-1, Drug: BR1015-2 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BR1015-AOne tablet administered alone | Drug | BR1015-A |
| BR1015-1One tablet administered alone | Drug | BR1015-1+BR1015-2 |
| BR1015-2One tablet administered alone | Drug | BR1015-1+BR1015-2 |
Primary outcome
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BR1015-A, BR1015-1 and BR1015-2 in people with Essential Hypertension, run by Boryung Pharmaceutical Co., Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Soo Hee Kim (02-708-8000, shkim0127@boryung.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCt of Fimasartan (time frame: From pre-dose (0 hour) through 48 hours post-dose in each period (Periods 1-4).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.