ClinicalTrials.gg
Not yet recruitingNCT07748702Updated Aug 6, 2026

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

A Phase 1 interventional study of CKD-339 and D311, D107 in Hypertension, sponsored by Chong Kun Dang Pharmaceutical. Not yet recruiting at 1 site in South Korea. Open to participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-06.

Sponsored by Chong Kun Dang Pharmaceutical · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
19 Years to 55 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hypertension

Browse trials for

03

In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's planned enrollment of 76 is below the median of 100 across 4,575 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Chong Kun Dang Pharmaceutical is the lead sponsor of 299 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy adults between the age of 19 and 55 (inclusive) at the time of screening test.
  2. Subjects with a (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 congenital or chronic diseases and who do not have medical examination results (such as electroencephalogram, , 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 form after fully understanding its contents.
  6. Subjects who had agreed to use medically appropriate 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

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 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 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 ( \< 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.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
76 participants (estimated)

Study arms

  • 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 · Drug: D311, D107

  • 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 · Drug: D311, D107

Interventions

  • DrugCKD-339

    QD, PO

    Also known as: Test

  • DrugD311, D107

    QD, PO

    Also known as: Reference

06

What researchers measure

Primary outcomes

  1. AUCt of CKD-339

    Area under the plasma CKD-339 concentration-time curve from 0 to t

    Time frame: From 0 to 72 hours postdose

  2. Cmax of CKD-339

    The maximum concentration of CKD-339 in plasma

    Time frame: From 0 to 72 hours postdose

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07748702
Responsible party
Sponsor
First posted
Aug 6, 2026
Start date
Aug 20, 2026 (estimated)
Primary completion
Oct 6, 2026 (estimated)
Completion
Oct 12, 2026 (estimated)
Last update
Aug 6, 2026

Study contacts

Taegon Hong, M.D.
Contact
tghong@bumin.co.kr
+82-2-2620-0251

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion