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Cardiovascular DiseasePhase 1NCT04478097

Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics in Healthy Volunteers

A Phase 1 study testing CKD-330 Tab. and D086 Tab. and CKD-333 Tab. in people with Cardiovascular Disease, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is a randomized, open, single-dose, 3 period partial replicated crossover-design study to investigate the pharmacokinetic profiles and safety of CKD-333 in healthy volunteers. Read more about this study

Who is it for?
Ages 19 to 54 yearsHealthy volunteers can take part
Conditions the study is for
Cardiovascular Disease
What is being tested?
CKD-330 Tab. and D086 Tab. and CKD-333 Tab.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteSouth Korea
Study dates
14 Jul 2020to 1 Jan 2021
Phase
Phase 1
Are there results?
None posted in the registry

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 54 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adults over the age of 19 years and under the age of 55 years at the time of screening
  • Individuals who had 17.5 kg/m2 ≤ Body Mass Index(BMI) < 30.5kg/m2 and men's total body weight ≥ 55 kg, women's total body weight ≥ 45 kg
  • BMI = Weight(kg)/ Height(m)2
  • Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years
  • Individuals who were deemed to be appropriate as study subjects following laboratory tests (hematology, blood chemistry, urinalysis, viral/bacterial, etc.) and vital signs, ECG etc. performed at screening
  • Individuals who signed an informed consent form and decided to participate in the study after being fully informed of the study prior to participation
  • Individuals who agreed proper contraception during the study and did consent to not donation of sperm 1 month after the last dose of study drug infusion
  • Individuals with the ability and willingness to participate the entire study period

Who cannot join

  • Individuals with a medical evidence or a history of clinically significant hepatobiliary, renal, neurologic, respiratory, digestive, endocrine, blood-oncology, urinary, cardiovascular, musculoskeletal or psychiatric
  • Individuals with a medical history of gastrointestinal disease (e.g., Crohn's disease and ulcer) or gastrectomy (excluding simple appendectomy or herniotomy) that may affect drug absorption
  • Individuals with the following results at screening test:
  • ALT or AST > 2x the upper limit of the normal range
  • Creatinine > upper limit of the normal range or eGFR with MDRD <60 ml/min/1.73 m2
  • ECG Result, QTc > 450msec
Show all 40Show fewer
  • CPK > UNL(upper normal limit) x 3.0
  • K > 5.5mEq/l
  • Hct < lower limit of the normal range
  • A history of regular alcohol consumption exceeding 21 units/week within the 3 months(1 unit = 10 g = 12.5 ml) prior to screening or individuals who cannot quit drinking from 48hr prior to the first dose to end of last blooding (1 drink (250 mL) of beer (5%) = 10 g; 1 drink (50 mL) of hard liquor (20%) = 8 g; 1 drink (125 mL) of wine (12%) = 12 g)
  • Individuals who smoked more than 20 cigarettes per day within 6 months prior to screening or cannot quit smoking during hospitalization period
  • Individuals who had been administered investigational product(s) of other clinical study or bioequivalence study within the 6 months prior to the first dose of this study
  • Following vital signs results at screening
  • Sitting systolic blood pressure ≥ 140 mmHg or < 90 mmHg
  • sitting diastolic blood pressure ≥90 mmHg or <60 mmHg
  • Individuals with a medical history of significant drug abuse within one year prior to the screening or positive for abuse drug in urine test results at screening
  • Individuals taking medication known to significantly induce or inhibit drug metabolizing enzymes within 30days before the first administration of clinical trial drug
  • Individuals who had taken prescription or nonprescription drugs within the 10 days prior to the first dose of investigational product(s)
  • Individuals who donated whole blood within the 2 months, or blood components within 1 month prior to the first dose of the investigational product(s)
  • Individuals with hypersensitivity to investigational products or the investigational products ingredients
  • Patients or conditions deemed to be at risk for using investigational products
  • Patient with hyperkalemia
  • Patients with hepatopathy
  • Patients with hereditary angioedema, ACE inhibitors or angiotensin 2 receptor antagonists who have a history of angioedema
  • Primary hyperaldosteronism
  • Patients with aortic valve stenosis, mitral (valve) stenosis, hypertrophic obstructive cardiomyopathy
  • Patients with ischemic heart disease, ischemic cardiovascular disease, cerebrovascular disease
  • Patients with Intravascular volume depletion
  • Patients with diabetes or kidney failure
  • Patients with renal artery stenosis
  • Patients with muscle disease
  • Patients with Hypothyroidism
  • Patients with a history of muscle toxicity when using statins or fibrates
  • Patients who have recently had a kidney transplant
  • Patients with history of shock
  • Individuals with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
  • Individuals who drunk grapefruit juice or caffeine more than 5 cup per day within 3 months prior to screening or cannot quit drinking during clinical trials period
  • Individuals who cannot eat standard meal in institution
  • Women who are pregnant or may be pregnant
  • Individuals who were deemed to be inappropriate to participate in the study by the investigator

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Jang Hee Hong

    Daejeon

Other trials in South Korea

About this study

Official title: A Randomized, Open, Single-dose, 3 Period Partial Replicated Crossover-design Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Administration of CKD-333 or Co-administration of CKD-330 and D086 in Healthy Volunteers Under Fasting Conditions

This study is a randomized, open, single-dose, 3 period partial replicated crossover-design study to investigate the pharmacokinetic profiles and safety of CKD-333 in healthy volunteers.

Read the detailed description

To healthy subjects of fifty-one (51), following treatments are administered dosing in each period and wash-out period is a minimum of 14 days.

Being tested
CKD-330 Tab. and D086 Tab., CKD-333 Tab.
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CKD-330 Tab. and D086 Tab.Drug

    Also called Reference

    1T

  • CKD-333 Tab.Drug

    Also called Test

    1T

Study groups in NCT04478097
Study groupRoleWhat they receive
Reference-Reference-TestExperimentalNot described
Receives: Drug: CKD-330 Tab. and D086 Tab.; Drug: CKD-333 Tab.
Reference-Test-ReferenceExperimentalNot described
Receives: Drug: CKD-330 Tab. and D086 Tab.; Drug: CKD-333 Tab.
Test-Reference-ReferenceExperimentalNot described
Receives: Drug: CKD-330 Tab. and D086 Tab.; Drug: CKD-333 Tab.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUCt of CKD-330, D086, CKD-333

    Area under the CKD-330/D086/CKD-333 concentration in blood-time curve from zero to final

    Measured: [Time Frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours]

  2. Cmax of CKD-330, D086, CKD-333

    The maximum CKD-330/D086/CKD-333 concentration in blood sampling time t

    Measured: [Time Frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2020
  2. Study start14 Jul 2020 (estimated)
  3. Primary completion5 Nov 2020 (estimated)
  4. Study completion1 Jan 2021 (estimated)

Resources

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
51 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04478097
Sponsor's protocol ID
A70_09BE2005
Status last verified
Jul 2020
First submitted
17 Jul 2020
Last updated
22 Jul 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kim JH, Song JH, Kim M, Hong JH, Sunwoo J, Jung JG. Pharmacokinetic Comparison of a Fixed-Dose Combination of Candesartan Cilexetil/Amlodipine/Atorvastatin Versus Co-administration of Individual Formulations in Healthy Participants. Adv Ther. 2024 Jul;41(7):2808-2825. doi: 10.1007/s12325-024-02869-y. Epub 2024 May 21.

    PubMed 38771476

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CKD-330 Tab. and D086 Tab. and CKD-333 Tab. in people with Cardiovascular Disease, 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 8 inclusion and 40 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: status not confirmed, as of the sponsor's last update on 22 Jul 2020. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUCt of CKD-330, D086, CKD-333 (time frame: [Time Frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours]). 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?

On the ClinicalTrials.gov record for NCT04478097, which also lists 1 linked publication.

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 22 Jul 2020.

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