HypertensionPhase 1NCT06281132
Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic After Oral Administration of CKD-341 and D956 in Healthy Adults
A Phase 1 study testing CKD-341, D956 in people with Hypertension, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
The objective was to evaluate and compare the pharmacokinetic profiles and safety after administration of test drug (CKD-341) and reference drugs (D956) in healthy adults. 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-341, D956
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Mar 2024to 14 May 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged between 19 to 55 years at the time of screening.
- Individuals who had 18.0 kg/m2 ≤ Body Mass Index (BMI) < 30.5 kg/m2 and whose body weight was ≥ 55 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 according to the laboratory tests (hematology, blood chemistry, urinalysis, serology, etc.), vital signs, 12-lead electrocardiogram (ECG), etc., performed at screening.
- Individuals who signed an informed consent form approved by the Institutional Review Board (IRB) of Jeonbuk National University Hospital and who decided to participate voluntarily in the study after being fully informed of the study objective, contents, etc. prior to participation.
- Individuals who consented to the use of reliable contraception (contraceptive methods other than hormones: use of condoms, intrauterine devices (IUD, IUS), tubal ligation, cervical cap, contraceptive diaphragm, etc.) during the clinical trial and not to donate sperm until 1 month after the last administration of investigational product(s).
- Individuals with the ability and willingness to participate the entire study period.
Who cannot join
- Individuals with medical evidence or a history (excluding a simple dental history of dental calculus, impacted tooth, wisdom tooth, etc.) of clinically significant hematological, renal, endocrine, respiratory, gastrointestinal(Active gastric ulcer), duodenal ulcer, etc.), urinary, cardiovascular (severe aortic valve stenosis, aArterial valve, mitral valve stenosis, obstructive hypertrophic cardiomyopathy, etc.), hepatic (severe hepatic impairment, etc.), psychiatric, neurologic, or immune diseases.
- Individuals with a medical history of gastrointestinal diseases (e.g., esophageal disorders such as esophageal achalasia or esophagostenosis, Crohn's disease) or operations (excluding simple appendectomy, herniotomy, or tooth extraction) that may affect drug absorption.
- Individuals with the following laboratory test result at screening:
- ALT or AST > 2x the upper limit of the normal range
- CK > 3x the upper limit of the normal range
- eGFR <60 mL/min/1.73 m2 using CKD-EPI formula
Show all 31Show fewer
- Individuals with a history of regular alcohol consumption exceeding 210 g/week within 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.
- Individuals who had taken investigational product(s) from other clinical trials or bioequivalence studies within 6 months prior to the first administration of the investigational product(s).
- Individuals with the following vital signs upon screening
- ☞ Systolic blood pressure ≥140 mmHg or <90 mmHg and/or a diastolic blood pressure ≥90 mmHg or <60 mmHg in sitting position.
- Individuals with a medical history of significant alcohol or drug abuse within 1 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 administration of the investigational product(s).
- Individuals who had taken prescription or nonprescription drugs within 10 days prior to the first administration of the investigational product(s).
- Individuals who donated whole blood within 2 months or blood components within 1 month or have given blood transfusion within 1 month prior to the first administration of the investigational product(s).
- Individuals with severe acute/chronic medical or psychological conditions, whose participation in the clinical trial and administration of the investigational products could increase the risk to the subjects or interfere with the interpretation of trial results.
- Individuals with hypersensitivity to the investigational product(s), components of the investigational product(s), or dihydropyridine drugs, thiazide diuretics, or sulfonamide drugs, or hereditary issues of intolerance etc.
- Patients with hereditary angioedema or with a history of angioedema when treated with ACE inhibitors or angiotensin II receptor antagonists.
- Patients with shock.
- Patients with anuria.
- Patients with biliary obstructive disease.
- Patients with diabetes or moderate to severe renal impairment who use aliskiren-containing preparations in combination.
- Patients with severe heart failure.
- Patients with Hypokalemia.
- Patients with hyponatremia, hypercalcemia.
- Patients with Hyperuricemia (with gout or uric acid stone).
- Patients with Addison's syndrome.
- Patients receiving lithium therapy.
- Patients taking terfenadine or astemizole (can cause QT prolongation and ventricular arrhythmias).
- Women who are pregnant or lactating.
- Individuals who were deemed inappropriate to participate in the study by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single Dose, 4-period Replicate Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-341 in Healthy Volunteers Under Fasting Conditions
The objective was to evaluate and compare the pharmacokinetic profiles and safety after administration of test drug (CKD-341) and reference drugs (D956) in healthy adults.
Read the detailed description
A randomized, open-label, single dose, 4-period replicate crossover study in healthy adults under fasting conditions
- Conditions
- Hypertension
- Being tested
- CKD-341, D956
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-341, D956Drug
Also called PO, Tablet
A single dose of 1 tablet under fasting condition
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | * Period 1: D956
* Period 2: CKD-341
* Period 3: D956
* Period 4: CKD-341 Receives: Drug: CKD-341, D956 |
| Sequence 2 | Experimental | * Period 1: CKD-341
* Period 2: D956
* Period 3: CKD-341
* Period 4: D956 Receives: Drug: CKD-341, D956 |
What is being measured
The primary outcome is the main question the study is designed to answer.
area under curve(AUC) of CKD-341, D956
Area under the CKD-341, D958 concentration in blood-time curve from zero to
Measured: Pre-dose(0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hours
Cmax of CKD-341, D956
The maximum CKD-341, D956 concentration in blood sampling time
Measured: Pre-dose(0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 6, 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 posted28 Feb 2024
- Study start22 Mar 2024
- Primary completion7 May 2024
- Study completion14 May 2024
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
- 51 participants (actual)
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
- NCT06281132
- Sponsor's protocol ID
- A126_03BE2316
- Status last verified
- May 2024
- First submitted
- 20 Feb 2024
- Last updated
- 28 May 2024
- 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 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, 4-period Replicate Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-341 in Healthy Volunteers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT06281132
- Acronym / sponsor ID
- A126_03BE2316
- Conditions
- Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- 7 May 2024 (actual)
- Study completion
- 14 May 2024 (actual)
- First posted
- 28 Feb 2024 (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.
The objective was to evaluate and compare the pharmacokinetic profiles and safety after administration of test drug (CKD-341) and reference drugs (D956) in healthy adults.
Detailed description
A randomized, open-label, single dose, 4-period replicate crossover study in healthy adults under fasting conditions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: CKD-341, D956* Period 1: D956 * Period 2: CKD-341 * Period 3: D956 * Period 4: CKD-341 |
| Sequence 2 | Experimental | Drug: CKD-341, D956* Period 1: CKD-341 * Period 2: D956 * Period 3: CKD-341 * Period 4: D956 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy adults aged between 19 to 55 years at the time of screening.
- Individuals who had 18.0 kg/m2 ≤ Body Mass Index (BMI) < 30.5 kg/m2 and whose body weight was ≥ 55 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 according to the laboratory tests (hematology, blood chemistry, urinalysis, serology, etc.), vital signs, 12-lead electrocardiogram (ECG), etc., performed at screening.
Key exclusion criteria (31 listed)
- Individuals with medical evidence or a history (excluding a simple dental history of dental calculus, impacted tooth, wisdom tooth, etc.) of clinically significant hematological, renal, endocrine, respiratory, gastrointestinal(Active gastric ulcer), duodenal ulcer, etc.), urinary, cardiovascular (severe aortic valve stenosis, aArterial valve, mitral valve stenosis, obstructive hypertrophic cardiomyopathy, etc.), hepatic (severe hepatic impairment, etc.), psychiatric, neurologic, or immune diseases.
- Individuals with a medical history of gastrointestinal diseases (e.g., esophageal disorders such as esophageal achalasia or esophagostenosis, Crohn's disease) or operations (excluding simple appendectomy, herniotomy, or tooth extraction) that may affect drug absorption.
- Individuals with the following laboratory test result at screening:
- Individuals with a history of regular alcohol consumption exceeding 210 g/week within 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-341, D956Also: PO, TabletA single dose of 1 tablet under fasting condition | Drug | Sequence 1, Sequence 2 |
Primary outcome
area under curve(AUC) of CKD-341, D956
Time frame: Pre-dose(0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hours
Area under the CKD-341, D958 concentration in blood-time curve from zero to
Cmax of CKD-341, D956
Time frame: Pre-dose(0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hours
The maximum CKD-341, D956 concentration in blood sampling time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Individual participant dataSharing planned: No
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
The record lists no contact. Use the official record to reach the sponsor.
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-341, D956 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 8 inclusion and 31 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: finished, as of the sponsor's last update on 28 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
area under curve(AUC) of CKD-341, D956 (time frame: Pre-dose(0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 6, 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?
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 28 May 2024.