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New combo pill for high blood pressure enters first human tests

NCT ID NCT07421401

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests a new combination pill (BR1015-A) containing two blood pressure medicines, Fimasartan and Indapamide, in 58 healthy adults. The goal is to see how the body absorbs and processes the drugs and to check for any safety issues. Participants will take the pill once on four separate occasions under fasting conditions. This study does not treat high blood pressure but gathers important information for future research.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fimasartan and Indapamide combination tablet
What this could lead to
If successful, this could lead to a new once-daily pill that helps control high blood pressure more conveniently.
What could go wrong
This is a very early (Phase 1) study in only 58 healthy people, not patients. It only checks how the drug is processed and basic safety; it cannot tell us if it actually works for hypertension.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 58 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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Other studies related to the condition(s) this trial covers.