Cardiovascular DiseasePhase 1NCT04611932
Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-333 Low Dose in Healthy Volunteers
A Phase 1 study testing CKD-330 Tab. and D090 Tab. and CKD-333 Tab. in people with Cardiovascular Disease, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
This study is a randomized, open-label, single dose, 3-period partial replicated crossover study to evaluate the pharmacokinetic profiles and safety of CKD-333 low dose in healthy volunteers under fasting conditions. 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 D090 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
- 11 Nov 2020to 27 Apr 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 approved by the IRB of Chonbuk National University Hospital and decided to participate in the study after being fully informed of the study prior to participation, including the objective, content and characteristics of the investigational product
- 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 (excluding a dental history of periodontal surgery, impacted wisdom teeth removal, etc.) of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or immune diseases.
- Individuals with a medical history of gastrointestinal disease (e.g., gullet disease such as esophageal achalasia and esophagostenosis and Crohn's disease) or operations (excluding simple appendectomy, herniotomy or tooth extraction) that may affect drug absorption
- Individuals with the following laboratory test results at screening:
- ALT or AST > 2x the upper limit of the normal range
- CK > 3x the upper limit of the normal range
- History of regular alcohol consumption exceeding 210 g/week within the 6 months prior to screening (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)
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- Individuals who smoked more than 20 cigarettes per day within 6 months prior to screening
- Individuals who had been administered investigational product(s) from 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 and/or sitting diastolic blood pressure ≥90 mmHg or <60 mmHg
- Individuals with a medical history of significant alcohol or drug abuse within one year prior to the screening
- Individuals who had taken any drug(s) known as a strong inducer(s) or inhibitor(s) of drug-metabolizing enzymes within 30 days prior to the first dose of investigational product(s)
- 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 severe acute/chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product(s) administration, or may interfere with the interpretation of study results
- Individuals with hypersensitivity to investigational products or the investigational products ingredients or dihydropyridine drugs
- Patient with hyperkalemia
- Patients with hepatopathy
- Patients with hereditary angioedema, ACE inhibitors or angiotensin Ⅱ 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 nephropathy (eGFR<60 ml/min/1.73 m2)
- Patients with renal artery stenosis
- Patients with muscle disease
- Patients with Hypothyroidism
- Women who are pregnant or may be pregnant
- Patients with a history of muscle toxicity when using statins or fibrates
- Patients who are taking glecaprevir/pibrentasvir
- Patients with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
- 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
Chonbuk National University Hospital
Jeonju
Min-Gul Kim, Professor
About this study
Official title: A Randomized, Open-label, Single Dose, 3-period Partial Replicated Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-333 Low Dose in Healthy Volunteers Under Fasting Conditions
This study is a randomized, open-label, single dose, 3-period partial replicated crossover study to evaluate the pharmacokinetic profiles and safety of CKD-333 low dose in healthy volunteers under fasting conditions.
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.
Reference drug: 1) Cantabell Tab. 8/5mg 2) Lipitor Tab. 10mg / Test drug: CKD-333 8/5/10mg Tab.
Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.
- Conditions
- Cardiovascular Disease
- Being tested
- CKD-330 Tab. and D090 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 D090 Tab.Drug
Also called Reference
1T
CKD-333 Tab.Drug
Also called Test
1T
| Study group | Role | What they receive |
|---|---|---|
| Reference-Reference-Test | Experimental | Not described Receives: Drug: CKD-330 Tab. and D090 Tab.; Drug: CKD-333 Tab. |
| Reference-Test-Reference | Experimental | Not described Receives: Drug: CKD-330 Tab. and D090 Tab.; Drug: CKD-333 Tab. |
| Test-Reference-Reference | Experimental | Not described Receives: Drug: CKD-330 Tab. and D090 Tab.; Drug: CKD-333 Tab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of CKD-330, D090, CKD-333
Area under the CKD-330/D090/CKD-333 concentration in blood-time curve from zero to final
Measured: Pre-dose (0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Cmax of CKD-330, D090, CKD-333
The maximum CKD-330/D090/CKD-333 concentration in blood sampling time t
Measured: Pre-dose (0 hour), post-dose 0.25, 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.
- First posted2 Nov 2020
- Study start11 Nov 2020 (estimated)
- Primary completion10 Mar 2021 (estimated)
- Study completion27 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies 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
- 51 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
- NCT04611932
- Sponsor's protocol ID
- A70_08BE1907
- Status last verified
- Oct 2020
- First submitted
- 27 Oct 2020
- Last updated
- 2 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim SY, Kwak YG, Kim MG, Moon SJ. Comparative pharmacokinetics of a candesartan/amlodipine/atorvastatin fixed-dose combination 8 mg/5 mg/10 mg versus separate tablets in healthy subjects: a partial replicated crossover study. Transl Clin Pharmacol. 2026 Mar;34(1):58-68. doi: 10.12793/tcp.2026.34.e2. Epub 2026 Mar 12.
PubMed 41970000
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, 3-period Partial Replicated Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-333 Low Dose in Healthy Volunteers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT04611932
- Acronym / sponsor ID
- A70_08BE1907
- Conditions
- Cardiovascular Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2020 (estimated)
- Primary completion
- 10 Mar 2021 (estimated)
- Study completion
- 27 Apr 2021 (estimated)
- First posted
- 2 Nov 2020 (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, 3-period partial replicated crossover study to evaluate the pharmacokinetic profiles and safety of CKD-333 low dose in healthy volunteers under fasting conditions.
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.
Reference drug: 1) Cantabell Tab. 8/5mg 2) Lipitor Tab. 10mg / Test drug: CKD-333 8/5/10mg Tab.
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
- 3
| Arm | Type | Receives |
|---|---|---|
| Reference-Reference-Test | Experimental | Drug: CKD-330 Tab. and D090 Tab., Drug: CKD-333 Tab. |
| Reference-Test-Reference | Experimental | Drug: CKD-330 Tab. and D090 Tab., Drug: CKD-333 Tab. |
| Test-Reference-Reference | Experimental | Drug: CKD-330 Tab. and D090 Tab., Drug: CKD-333 Tab. |
Who may qualify
- Ages
- 19 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
- 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 approved by the IRB of Chonbuk National University Hospital and decided to participate in the study after being fully informed of the study prior to participation, including the objective, content and characteristics of the investigational product
Key exclusion criteria (32 listed)
- Individuals with a medical evidence or a history (excluding a dental history of periodontal surgery, impacted wisdom teeth removal, etc.) of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or immune diseases.
- Individuals with a medical history of gastrointestinal disease (e.g., gullet disease such as esophageal achalasia and esophagostenosis and Crohn's disease) or operations (excluding simple appendectomy, herniotomy or tooth extraction) that may affect drug absorption
- Individuals with the following laboratory test results at screening:
- History of regular alcohol consumption exceeding 210 g/week within the 6 months prior to screening (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
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-330 Tab. and D090 Tab.Also: Reference1T | Drug | Reference-Reference-Test, Reference-Test-Reference, Test-Reference-Reference |
| CKD-333 Tab.Also: Test1T | Drug | Reference-Reference-Test, Reference-Test-Reference, Test-Reference-Reference |
Primary outcome
AUCt of CKD-330, D090, CKD-333
Time frame: Pre-dose (0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Area under the CKD-330/D090/CKD-333 concentration in blood-time curve from zero to final
Cmax of CKD-330, D090, CKD-333
Time frame: Pre-dose (0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
The maximum CKD-330/D090/CKD-333 concentration in blood sampling time t
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Derived from this study: PubMed 41970000Kim SY, Kwak YG, Kim MG, Moon SJ. Comparative pharmacokinetics of a candesartan/amlodipine/atorvastatin fixed-dose combination 8 mg/5 mg/10 mg versus separate tablets in healthy subjects: a partial replicated crossover study. Transl Clin Pharmacol. 2026 Mar;34(1):58-68. doi: 10.12793/tcp.2026.34.e2. Epub 2026 Mar 12.
- 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. This study is not recruiting at the moment.
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-330 Tab. and D090 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 32 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 2 Nov 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?
Contact Min-Gul Kim, Professor (+82-63-259-3480, mgkim@jbcp.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCt of CKD-330, D090, CKD-333 (time frame: Pre-dose (0 hour), post-dose 0.25, 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 NCT04611932, 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 2 Nov 2020; AzTrials last refreshed its copy on 7 Nov 2026.