HypertensionPhase 1NCT05571813
Exploratory Trial to Evaluate the Pharmacokinetic Properties and Safety of CKD-341 in Healthy Subjects
A Phase 1 study testing CKD-341 in people with Hypertension, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
Exploratory Trial to Evaluate the Pharmacokinetic Properties and Safety of CKD-341 in Healthy Subjects Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- CKD-341
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Nov 2022to 23 Dec 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male volunteers, aged ≥ 19 years old at the time of screening
- Those with a body mass index (BMI) of 17.5 kg/m2 or more and less than 30.5 kg/m2
- Those who do not have congenital or chronic diseases and have no pathological symptoms or findings as a result of medical examination
- Clinical laboratory tests (hematology tests, blood chemistry tests, urinalysis, serological tests, etc.) conducted by the principal investigator(or the investigator who has been delegated) according to the characteristics of the drug and screening tests such as vital signs and electrocardiogram tests Result Those who are judged to be suitable as test subjects
- Before participating in the trial, the purpose and contents of the trial were fully explained, and the participants agreed to participate in this study voluntarily who signed
- After the first administration of the clinical trial drug, for up to 14 days after the last administration of the investigational drug, you, your spouse, or your partner must agree to maintain the use of an appropriate medically acceptable method of contraception* except for hormonal contraceptives and not donate sperm or eggs ruler
- Those who have the ability and willingness to participate during the entire examination period
Who cannot join
- A history of clinically significant blood, renal, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, psychiatric, neurological, or immune disease (except for simple dental history of calculus, impacted teeth, wisdom teeth, etc.) or evidence one who has 1-1. Patients with hypersensitivity or a history of hypersensitivity to this drug or ingredients contained in this drug, dihydropyridine derivatives, thiazide diuretics, or sulfonamide drugs 1-2. Pregnant (2nd and 3rd trimester) or women who may be pregnant 1-3. Lactating women 1-4. Patients with biliary atresia 1-5. Patient with Severely liver dysfunction 1-6. Patient with Severely aortic valvular stenosis 1-7. Shock patient 1-8. Patients with genetic problems such as intolerance to this drug's additives 1-9. Patients with diabetes or moderate to severe renal impairment (glomerular filtration rate <60mL/min/1.73m2) who used aliskiren-containing agents in combination 1-10. Patients with anuria 1-11. Patients with severe renal failure (creatinine clearance <30 mL/min) 1-12. Patients with refractory hypokalemia 1-13. Patients with hyponatremia and hypercalcemia 1-14. Patients with symptomatic hyperuricemia (history of gout or urolithiasis) 1-15. Untreated Addison's syndrome patients 1-16. Patients receiving lithium therapy 1-17. Patients taking terfenadine or astemizole
- Those with a history of gastrointestinal diseases (esophageal diseases such as achalasia or esophageal stricture, Crohn's disease) or surgery(except simple appendicectomy, hernia surgery, and tooth extraction surgery) that may affect drug absorption ruler
- A person who shows the following values as a result of conducting a clinical laboratory test
- ALT or AST > 2 times the upper limit of the normal range
- Smokers who smoked more than 20 cigarettes a day within 6 months of screening
- Those who have taken other clinical investigational drugs or bioequivalence investigational drugs within 6 months before the first administration of the clinical investigational drug
Show all 16Show fewer
- Those who meet the following as a result of measuring vital signs at screening
- Those who have a systolic blood pressure of less than 90 mmHg or more than 140 mmHg or a diastolic blood pressure of less than 60 mmHg or more than 90 mmHg in the sitting position
- Severe bradycardia (less than 50 beats/min)
- Those with a history of regular alcohol intake within 1 month of screening
- More than 14 drinks/Week for women
- More than 21 drinks/Week for men
- A person who has taken a drug known to significantly induce or inhibit drug metabolizing enzymes within 30 days before the first administration of the clinical trial drug
- Those who have taken prescription or non-prescription drugs within 10days prior to the first administration of clinical trial drugs
- Those who have donated whole blood within 2 months before the first administration of the clinical trial drug, donated component blood within 1 month, received blood transfusion within 1 month, or have plans for the trial during the clinical trial period
- Those who are judged by the principal investigator (or the person in charge of the test who has been delegated) for reasons other than the above selection/exclusion criteria and are judged unsuitable for participation in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Fasted, Single-dose, Three-way Crossover Study to Compare the Pharmacokinetic Characteristics and Safety Between Administration of CKD-341 and Administration of D958 in Healthy Adults
Exploratory Trial to Evaluate the Pharmacokinetic Properties and Safety of CKD-341 in Healthy Subjects
Read the detailed description
An open-label, randomized, fasted, single-dose, three-way crossover study to compare the pharmacokinetic characteristics and safety between administration of CKD-341 and administration of D958 in healthy adults
- Conditions
- Hypertension
- Being tested
- CKD-341
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-341Drug
Also called D958
A single dose of 1tablets under fasting condition
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Period1: D958 Period2: CKD-341 Formulation I Period3: CKD-341 Formulation II Receives: Drug: CKD-341 |
| Sequence 2 | Experimental | Period1: CKD-341 Formulation II Period2: D958 Period3: CKD-341 Formulation I Receives: Drug: CKD-341 |
| Sequence 3 | Experimental | Period1: CKD-341 Formulation I Period2: CKD-341 Formulation II Period3: D958 Receives: Drug: CKD-341 |
| Sequence 4 | Experimental | Period1: CKD-341 Formulation II Period2: CKD-341 Formulation I Period3: D958 Receives: Drug: CKD-341 |
| Sequence 5 | Experimental | Period1: CKD-341 Formulation I Period2: D958 Period3: CKD-341 Formulation II Receives: Drug: CKD-341 |
| Sequence 6 | Experimental | Period1: D958 Period2: CKD-341 Formulation II Period3: CKD-341 Formulation I Receives: Drug: CKD-341 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of CKD-341, D958
Area under the CKD-341, D958 concentration in blood-time curve from zero to final
Measured: Pre-dose(0 hour), post-dose 0.25, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72 hours
Cmax of CKD-341, D958
The maximum CKD-341, D958 concentration in blood sampling time
Measured: Pre-dose(0 hour), post-dose 0.25, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 5, 6, 7, 8, 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 posted7 Oct 2022
- Study start2 Nov 2022
- Primary completion4 Dec 2022
- Study completion23 Dec 2022
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
- 30 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
- NCT05571813
- Sponsor's protocol ID
- A126_01BE2205P
- Status last verified
- Oct 2022
- First submitted
- 6 Oct 2022
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Fasted, Single-dose, Three-way Crossover Study to Compare the Pharmacokinetic Characteristics and Safety Between Administration of CKD-341 and Administration of D958 in Healthy Adults
- ClinicalTrials.gov ID
- NCT05571813
- Acronym / sponsor ID
- A126_01BE2205P
- Conditions
- Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 4 Dec 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 7 Oct 2022 (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.
Exploratory Trial to Evaluate the Pharmacokinetic Properties and Safety of CKD-341 in Healthy Subjects
Detailed description
An open-label, randomized, fasted, single-dose, three-way crossover study to compare the pharmacokinetic characteristics and safety between administration of CKD-341 and administration of D958 in healthy adults
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: CKD-341Period1: D958 Period2: CKD-341 Formulation I Period3: CKD-341 Formulation II |
| Sequence 2 | Experimental | Drug: CKD-341Period1: CKD-341 Formulation II Period2: D958 Period3: CKD-341 Formulation I |
| Sequence 3 | Experimental | Drug: CKD-341Period1: CKD-341 Formulation I Period2: CKD-341 Formulation II Period3: D958 |
| Sequence 4 | Experimental | Drug: CKD-341Period1: CKD-341 Formulation II Period2: CKD-341 Formulation I Period3: D958 |
| Sequence 5 | Experimental | Drug: CKD-341Period1: CKD-341 Formulation I Period2: D958 Period3: CKD-341 Formulation II |
| Sequence 6 | Experimental | Drug: CKD-341Period1: D958 Period2: CKD-341 Formulation II Period3: CKD-341 Formulation I |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy male volunteers, aged ≥ 19 years old at the time of screening
- Those with a body mass index (BMI) of 17.5 kg/m2 or more and less than 30.5 kg/m2
- Those who do not have congenital or chronic diseases and have no pathological symptoms or findings as a result of medical examination
- Clinical laboratory tests (hematology tests, blood chemistry tests, urinalysis, serological tests, etc.) conducted by the principal investigator(or the investigator who has been delegated) according to the characteristics of the drug and screening tests such as vital signs and electrocardiogram tests Result Those who are judged to be suitable as test subjects
- Before participating in the trial, the purpose and contents of the trial were fully explained, and the participants agreed to participate in this study voluntarily who signed
Key exclusion criteria (16 listed)
- A history of clinically significant blood, renal, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, psychiatric, neurological, or immune disease (except for simple dental history of calculus, impacted teeth, wisdom teeth, etc.) or evidence one who has 1-1. Patients with hypersensitivity or a history of hypersensitivity to this drug or ingredients contained in this drug, dihydropyridine derivatives, thiazide diuretics, or sulfonamide drugs 1-2. Pregnant (2nd and 3rd trimester) or women who may be pregnant 1-3. Lactating women 1-4. Patients with biliary atresia 1-5. Patient with Severely liver dysfunction 1-6. Patient with Severely aortic valvular stenosis 1-7. Shock patient 1-8. Patients with genetic problems such as intolerance to this drug's additives 1-9. Patients with diabetes or moderate to severe renal impairment (glomerular filtration rate <60mL/min/1.73m2) who used aliskiren-containing agents in combination 1-10. Patients with anuria 1-11. Patients with severe renal failure (creatinine clearance <30 mL/min) 1-12. Patients with refractory hypokalemia 1-13. Patients with hyponatremia and hypercalcemia 1-14. Patients with symptomatic hyperuricemia (history of gout or urolithiasis) 1-15. Untreated Addison's syndrome patients 1-16. Patients receiving lithium therapy 1-17. Patients taking terfenadine or astemizole
- Those with a history of gastrointestinal diseases (esophageal diseases such as achalasia or esophageal stricture, Crohn's disease) or surgery(except simple appendicectomy, hernia surgery, and tooth extraction surgery) that may affect drug absorption ruler
- A person who shows the following values as a result of conducting a clinical laboratory test
- Smokers who smoked more than 20 cigarettes a day within 6 months of screening
- Those who have taken other clinical investigational drugs or bioequivalence investigational drugs within 6 months before the first administration of the clinical investigational drug
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-341Also: D958A single dose of 1tablets under fasting condition | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
Primary outcome
AUCt of CKD-341, D958
Time frame: Pre-dose(0 hour), post-dose 0.25, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72 hours
Area under the CKD-341, D958 concentration in blood-time curve from zero to final
Cmax of CKD-341, D958
Time frame: Pre-dose(0 hour), post-dose 0.25, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72 hours
The maximum CKD-341, D958 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 22 Mar 2023.
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 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 7 inclusion and 16 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 22 Mar 2023. 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?
AUCt of CKD-341, D958 (time frame: Pre-dose(0 hour), post-dose 0.25, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 5, 6, 7, 8, 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 22 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.