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Can a new blood pressure pill match the original?

NCT ID NCT07748702

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This trial is testing two experimental versions of a blood pressure drug, called D311 and D107, against the original medication, CKD-339. Healthy adults aged 19 to 55 will receive a single dose of each version in a random order to compare how the drug is absorbed and processed in the body, and to check for any safety concerns. The goal is to see if these new versions behave similarly to the original, which could lead to more options for managing high blood pressure.

What this could mean

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

Active substance
CKD-339 (an experimental hypertension drug) and two test versions, D311 and D107
What this could lead to
If successful, this could support the development of a new formulation of a blood pressure medication that is as safe and effective as the existing one, potentially offering more options for treating hypertension.
What could go wrong
This is an early-phase study in healthy volunteers, not people with hypertension. It focuses on how the drug is processed and safety, not on lowering blood pressure. Results may not predict real-world effectiveness or long-term safety.

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 76 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Oct 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 to 55 years

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: 1. Healthy adults between the age of 19 and 55 (inclusive) at the time of screening test. 2. Subjects with a body mass index(BMI) between 18 and 30 kg/m2(BMI = Weight(kg)/ Height(m)2) * Male subjects weighing at least 50 kg * Female subjects weighing at least 45 kg 3. Subjects who do not have clinically meaningful congenital or chronic diseases and who do not have medical examination results (such as electroencephalogram, electrocardiogram, chest and gastroscopy or gastrointestinal radiography, if necessary) during screening visits. 4. Subjects judged by investigators to be suitable for screening tests based on laboratory tests (e.g., blood tests, urine tests) and ECG, which were conducted according to the characteristics of the IP. 5. Subjects who voluntarily signed and dated the informed consent form after fully understanding its contents. 6. Subjects who had agreed to use medically appropriate contraceptive methods\* to exclude the possibility of pregnancy from the first dose of the IP to 14 days after the last dose, and not to donate sperm or ovum. * contraceptive methods: Combination use of intrauterine device (IUD) or system (IUS), vasectomy, tubal ligation, tubal occlusion and barrier methods of contraception (male condoms, female condoms, cervical caps, contraceptive diaphragm, sponges, etc.) or the use of combined spermicide, involves the simultaneous use of two or more barrier methods. Exclusion Criteria: 1. Subjects who have taken a drug metabolase-inducing and inhibiting drug such as barbitals within one month prior to the first dosing date or a drug that may interfere with this test within 10 days prior to the first dose of IP. 2. Subjects who had been administered investigational product from other clinical study or bioequivalence study within the 6 months prior to the first dose of IP. 3. Subjects who donated whole blood within 8 weeks, or blood components within 2 weeks prior to the first dose of IP. 4. Subjects who have a history of gastrointestinal resection that may affect the absorption of drugs. 5. Subjects with a history of regular alcohol consumption meeting any of the following criteria within 1 month prior to the first dose of IP. * Man: average alcohol consumption \> 21 cups/weeks * Woman: average alcohol consumption \> 14 cups/weeks 6. Patients with the following conditions * Patients who have a history of hypersensitivity to main or component of clinical trial drugs and other dihydropyridine drugs * Patients on angiotensin converting enzyme (ACE) inhibitor or not more than 36 hours after discontinuation of administration * Patients with a history of angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor antagonists (ARB) administration * Patients with hereditary or idiopathic angioedema * Patients with severe liver failure, cirrhosis or biliary obstruction, bile congestion * Patients with diabetes or moderate to severe renal impairment (eGFR \< 60mL/min/1.73m2) who have been co-administered with alliskyrene * Patients with primary aldosteronism * Shock patients (including cardiac shock) * Patients with severe aortic valve stenosis * Patients with unstable angina * Patients within one month of the onset of myocardial infarction 7. Subjects with a history of psychiatric disorders. 8. Subjects who are considered unsuitable for participation in this bioequivalence study by the Investigator (or delegated Sub-investigator) for reasons other than the inclusion and exclusion criteria listed above. 9. Female subjects who are pregnant, suspected of being pregnant, or breastfeeding.

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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

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bumin Hospital

    Seoul, South Korea

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