Cardiovascular DiseasesPhase 1CKD-333NCT04627207
A Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of CKD-333 or Co-administration of CKD-333 and D085 in Healthy Volunteers
A Phase 1 study testing CKD-330 1 Tab. and D085 1 Tab. and CKD-333 1 Tab in people with Cardiovascular Diseases, run by Chong Kun Dang Pharmaceutical.
Trial summary
A clinical trial to evaluate the safety and pharmacokinetic characteristics of CKD-333 or Co-administration of CKD-333 and D085 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 Diseases
- What is being tested?
- CKD-330 1 Tab. and D085 1 Tab. and CKD-333 1 Tab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Nov 2020to 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 adult volunteers aged 19≤ ~ <55-year-old.
- Those who have body weight ≥ 55kg (men) or ≥ 45kg (women), with calculated body mass index(BMI) of 17.5 ≤ ~ < 30.5 kg/m2
- Those who have no congenital/chronic diseases, abnormal symptoms.
- Those who were deemed to eligible for participation of clinical trial by laboratory tests, vital signs and 12-lead ECG etc.
- Those who voluntarily decide to participate and agree to comply with the cautions and fully understanding the detailed description of this clinical trial.
- Those who consent to proper contraception during the study period and do not donate sperm until 14 days after the last administration of investigational product. And those who consent not to become pregnant or breastfeeding.
- Those who have ability and willingness to participate in clinical trial
Who cannot join
- Those who have medical history or medical symptom of liver, kidney, nervous system, respiratory system, digestive system, endocrine system, blood/tumor, urinary system, cardiovascular system, musculoskeletal disease, or mental disease.
- Those who have past medical history of gastrointestinal disorder (Crohn's disease, ulcerative colitis, etc. except simple appendectomy or hernia surgery), which affect the absorption of drug.
- Those who have the test results written below,
- AST or ALT are 2 times higher than upper normal range
- Creatinine is upper normal range or eGFR (estimated Glomerular Filtration Rate, which is calculated by MDRD) < 60 mL/min/1.73m2
- QTc is higher than 450msec measured by 12-lead ECG
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- CPK is 3 times higher than upper normal range
- Serum Potassium is higher than 5.5 mEq/L
- Hematocrit is under normal range
- Those who exceed alcohol consumption criteria (21 units/week within 3 months) prior to first administration of investigational product. Or Those who can't quit drinking alcohol from 48 hours to end of bleeding time point.
- Those who exceed smoke criteria (20 cigarettes/day within 6 months) prior to first administration of investigational product. Or Those who can't quit smoking during hospitalization.
- Those who have participated in other clinical trial and received Investigational product within 6 month prior to the first administration of drug.
- Those who have the test results written below,
- Systolic blood pressure ≥140 mmHg or <90 mmHg
- Diastolic blood pressure ≥90 mmHg or <60 mmHg
- Those who have a drug abuse history within one year prior to first administration of investigational product or positive reaction on urine drug screening test.
- Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of investigational product.
- Those who received following drugs, which may affect results of clinical trial and safety.
- Ethical-the-counter (ETC) drugs or Over-the-counter (OTC) drugs within 10 days before the first administration of the investigational drug (especially Glecaprevir, Pibrentasvir).
- Those who donated whole blood within 2 months or apheresis within 1 month or received transfusion within 1 month.
- Those who have history of hypersensitivity to active pharmaceutical ingredient or Dihydropyridine or Aspirin, antibiotics etc.
- Those who deemed to ineligible for participation of clinical trial,
- 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 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
- Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
- Those who took caffeine or grapefruit within 3 months(5 cups/day) (before the first administration of investigational product) and can't stop taking caffeine or grapefruit until the end of clinical trial.
- Those who can't eat standard meal during hospitalization.
- Those who are pregnant or breastfeeding.
- Those who are deemed to ineligible for participation of clinical trial by investigators.
Trial locations and contacts
No sites are listed yet.
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 D085 in Healthy Volunteers Under Fasting Conditions
A clinical trial to evaluate the safety and pharmacokinetic characteristics of CKD-333 or Co-administration of CKD-333 and D085 in healthy volunteers
Read the detailed description
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 D085 in healthy volunteers under fasting conditions
- Conditions
- Cardiovascular Diseases
- Being tested
- CKD-330 1 Tab. and D085 1 Tab., CKD-333 1 Tab
- Keywords
- CKD-333
- 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 1 Tab. and D085 1 Tab.Drug
Other names: Reference
CKD-333 1 TabDrug
Other names: Test
| Study group | Role | What they receive |
|---|---|---|
| Reference-Reference-Test | Experimental | Sequence 1 Receives: Drug: CKD-330 1 Tab. and D085 1 Tab.; Drug: CKD-333 1 Tab |
| Reference-Test-Reference | Experimental | Sequence 2 Receives: Drug: CKD-330 1 Tab. and D085 1 Tab.; Drug: CKD-333 1 Tab |
| Test-Reference-Reference | Experimental | Sequence 3 Receives: Drug: CKD-330 1 Tab. and D085 1 Tab.; Drug: CKD-333 1 Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of CKD-330, D085, CKD-333
Area under the CKD-330/D085/CKD-333 concentration in blood-time curve from zero to final
Measured: 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
Cmax of CKD-330, D085, CKD-333
The maximum CKD-330/D085/CKD-333 concentration in blood sampling time t
Measured: 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.
- First posted13 Nov 2020
- Study startNov 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionApr 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 DiseasesStudies 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
- Investigators
- Hong Jang Hee, M.D., Principal investigator, Chungnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627207
- Sponsor's protocol ID
- A70_10BE2006
- Acronym
- CKD-333
- Status last verified
- Nov 2020
- First submitted
- 11 Nov 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 D085 in Healthy Volunteers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT04627207
- Acronym / sponsor ID
- CKD-333 / A70_10BE2006
- Conditions
- Cardiovascular Diseases
- Keywords
- CKD-333
- 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
- Nov 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 13 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.
A clinical trial to evaluate the safety and pharmacokinetic characteristics of CKD-333 or Co-administration of CKD-333 and D085 in healthy volunteers
Detailed description
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 D085 in healthy volunteers under fasting conditions
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 1 Tab. and D085 1 Tab., Drug: CKD-333 1 TabSequence 1 |
| Reference-Test-Reference | Experimental | Drug: CKD-330 1 Tab. and D085 1 Tab., Drug: CKD-333 1 TabSequence 2 |
| Test-Reference-Reference | Experimental | Drug: CKD-330 1 Tab. and D085 1 Tab., Drug: CKD-333 1 TabSequence 3 |
Who may qualify
- Ages
- 19 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy adult volunteers aged 19≤ ~ <55-year-old.
- Those who have body weight ≥ 55kg (men) or ≥ 45kg (women), with calculated body mass index(BMI) of 17.5 ≤ ~ < 30.5 kg/m2
- Those who have no congenital/chronic diseases, abnormal symptoms.
- Those who were deemed to eligible for participation of clinical trial by laboratory tests, vital signs and 12-lead ECG etc.
- Those who voluntarily decide to participate and agree to comply with the cautions and fully understanding the detailed description of this clinical trial.
Key exclusion criteria (41 listed)
- Those who have medical history or medical symptom of liver, kidney, nervous system, respiratory system, digestive system, endocrine system, blood/tumor, urinary system, cardiovascular system, musculoskeletal disease, or mental disease.
- Those who have past medical history of gastrointestinal disorder (Crohn's disease, ulcerative colitis, etc. except simple appendectomy or hernia surgery), which affect the absorption of drug.
- Those who have the test results written below,
- Those who exceed alcohol consumption criteria (21 units/week within 3 months) prior to first administration of investigational product. Or Those who can't quit drinking alcohol from 48 hours to end of bleeding time point.
- Those who exceed smoke criteria (20 cigarettes/day within 6 months) prior to first administration of investigational product. Or Those who can't quit smoking during hospitalization.
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 1 Tab. and D085 1 Tab.Other names: Reference | Drug | Reference-Reference-Test, Reference-Test-Reference, Test-Reference-Reference |
| CKD-333 1 TabOther names: Test | Drug | Reference-Reference-Test, Reference-Test-Reference, Test-Reference-Reference |
Primary outcome
AUCt of CKD-330, D085, CKD-333
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
Area under the CKD-330/D085/CKD-333 concentration in blood-time curve from zero to final
Cmax of CKD-330, D085, CKD-333
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 maximum CKD-330/D085/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 13 Nov 2020.
- Derived from this study: PubMed 38771476Kim 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.
- 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.
Hong Jang Hee, M.D. principal investigator
Chungnam National University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CKD-330 1 Tab. and D085 1 Tab. and CKD-333 1 Tab in people with Cardiovascular Diseases, run by Chong Kun Dang Pharmaceutical.
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 7 inclusion and 41 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 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Hong Jang Hee, M.D. (+82-42-280-6940, boniii@cnu.ac.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, D085, CKD-333 (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 NCT04627207, 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 13 Nov 2020.