HypertensionPhase 1NCT07748702
Clinical Study to Evaluate the Pharmacokinetics and Safety of CKD-339 in Healthy Volunteers
A Phase 1 study testing CKD-339 and D311, D107 in people with Hypertension, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
This study is a randomized, open-label, single dose, crossover study to evaluate the pharmacokinetics and safety of CKD-339 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- CKD-339 and D311, D107
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Aug 2026to 12 Oct 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults between the age of 19 and 55 (inclusive) at the time of screening test.
- 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
- 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.
- 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.
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- Subjects who voluntarily signed and dated the informed consent form after fully understanding its contents.
- 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.
Who cannot join
- 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.
- 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.
- Subjects who donated whole blood within 8 weeks, or blood components within 2 weeks prior to the first dose of IP.
- Subjects who have a history of gastrointestinal resection that may affect the absorption of drugs.
- 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
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- Woman: average alcohol consumption > 14 cups/weeks
- 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
- Subjects with a history of psychiatric disorders.
- 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.
- Female subjects who are pregnant, suspected of being pregnant, or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Bumin Hospital
Seoul
Taegon Hong, M.D., +82-2-2620-0251, tghong@bumin.co.kr
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- CKD-339, D311, D107
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-339Drug
Also called Test
QD, PO
D311, D107Drug
Also called Reference
QD, PO
| Study group | Role | What they receive |
|---|---|---|
| Sequence A(Reference-Test) | Experimental | 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) Receives: Drug: CKD-339; Drug: D311, D107 |
| Sequence B(Test-Reference) | Experimental | 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) Receives: Drug: CKD-339; Drug: D311, D107 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of CKD-339
Area under the plasma CKD-339 concentration-time curve from 0 to t
Measured: From 0 to 72 hours postdose
Cmax of CKD-339
The maximum concentration of CKD-339 in plasma
Measured: From 0 to 72 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start20 Aug 2026 (estimated)
- Primary completion6 Oct 2026 (estimated)
- Study completion12 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- 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
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748702
- Sponsor's protocol ID
- A164_01BE2511
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07748702
- Acronym / sponsor ID
- A164_01BE2511
- Conditions
- Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 6 Oct 2026 (estimated)
- Study completion
- 12 Oct 2026 (estimated)
- First posted
- 6 Aug 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.
This study is a randomized, open-label, single dose, crossover study to evaluate the pharmacokinetics and safety of CKD-339 in healthy volunteers.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A(Reference-Test) | Experimental | Drug: CKD-339, Drug: D311, D107Period 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) |
| Sequence B(Test-Reference) | Experimental | Drug: CKD-339, Drug: D311, D107Period 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) |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy adults between the age of 19 and 55 (inclusive) at the time of screening test.
- Subjects with a body mass index(BMI) between 18 and 30 kg/m2(BMI = Weight(kg)/ Height(m)2)
- 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.
- 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.
- Subjects who voluntarily signed and dated the informed consent form after fully understanding its contents.
Key exclusion criteria (22 listed)
- 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.
- 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.
- Subjects who donated whole blood within 8 weeks, or blood components within 2 weeks prior to the first dose of IP.
- Subjects who have a history of gastrointestinal resection that may affect the absorption of drugs.
- Subjects with a history of regular alcohol consumption meeting any of the following criteria within 1 month prior to the first dose of IP.
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 |
|---|---|---|
| CKD-339Also: TestQD, PO | Drug | Sequence A(Reference-Test), Sequence B(Test-Reference) |
| D311, D107Also: ReferenceQD, PO | Drug | Sequence A(Reference-Test), Sequence B(Test-Reference) |
Primary outcome
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
Cmax of CKD-339
Time frame: From 0 to 72 hours postdose
The maximum concentration of CKD-339 in plasma
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 6 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CKD-339 and D311, D107 in people with Hypertension, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
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 9 inclusion and 22 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 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Taegon Hong, M.D. (+82-2-2620-0251, tghong@bumin.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCt of CKD-339 (time frame: From 0 to 72 hours postdose). The study lists 2 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 6 Aug 2026.