Clinical Study to Evaluate the Pharmacokinetics and Safety of CKD-339 in Healthy Volunteers

July 31, 2026 updated by: Chong Kun Dang Pharmaceutical

An Open Label, Randomized, Single Dose, Crossover, Phase I Study to Evaluate the Pharmacokinetics and the Safety of D311 and D107 Compared to CKD-339 in Healthy Adult Volunteers

This study is a randomized, open-label, single dose, crossover study to evaluate the pharmacokinetics and safety of CKD-339 in healthy volunteers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

To 76 healthy subjects, following treatments, are administered dosing in each period and wash-out period is 14 days.

Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sequence A(Reference-Test)
Period 1: A single oral dose of 2 tablets under fasting condition(D311, D107), Period 2: A single oral dose of 1 tablet under fasting condition(CKD-339)
Drug: CKD-339
QD, PO
Other Names:
  • Test
Drug: D311, D107
QD, PO
Other Names:
  • Reference
Experimental: Sequence B(Test-Reference)
Period 1: A single oral dose of 1 tablet under fasting condition(CKD-339), Period 2: A single oral dose of 2 tablets under fasting condition(D311, D107)
Drug: CKD-339
QD, PO
Other Names:
  • Test
Drug: D311, D107
QD, PO
Other Names:
  • Reference

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
AUCt of CKD-339
Time Frame: From 0 to 72 hours postdose
Area under the plasma CKD-339 concentration-time curve from 0 to t
From 0 to 72 hours postdose
Cmax of CKD-339
Time Frame: From 0 to 72 hours postdose
The maximum concentration of CKD-339 in plasma
From 0 to 72 hours postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chong Kun Dang Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 6, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 12, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A164_01BE2511

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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