HypertensionPhase 1NCT05834595
A Clinical Trial to Compare the Pharmacokinetic and Safety of CKD-828
A Phase 1 study testing CKD-828, D064, D701 in people with Hypertension, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
A clinical trial to compare the pharmacokinetic and safety of CKD-828 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-828, D064, D701
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 May 2023to 26 Jul 2023
- 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 adult aged ≥ 19 at screening
- Body mass index (BMI) of 17.5 kg/m2 or more and less than 30.5kg/m2 and Body weight ≥ 55kg
- Those who do not have congenital or chronic diseases and have no pathological symptoms or findings as a result of medical examination
- A person who is deemed suitable as a subject as a result of screening such as clinical laboratory examination (hematology, blood chemistry, urinalysis, serological tests, etc.), vital signs, electrocardiogram examination, etc.
- A person who has received a sufficient explanation of the purpose and contents of the clinical trial and has agreed in writing voluntarily to participate in the clinical trial
- A person who has agreed to use appropriate contraception and not donate sperm or eggs until 14 days after the first administration of the drug and the last administration of the drug
- Those who have the ability and willingness to participate during the entire study 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 on who has
- Those with a history of gastrointestinal diseases or surgery (expect 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 investigational product or bioequivalence investigational product within 6 months before the first administration of the investigational product
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 investigational product
- Those who have taken prescription or non-prescription drugs within 10 days prior to the first administration of investigational product
- Those who have donated whole blood within 2 months before the first administration of the investigational product, 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 reason other than the above selection/exclusion criteria and are judged unsuitable for participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Fasted, Single-dose, 2-sequence, 4-period, Replicate Crossover Study to Compare the Pharmacokinetic and Safety Between Administration of CKD-828 20/2.5mg and Administration of D064, D701 in Healthy Adults
A clinical trial to compare the pharmacokinetic and safety of CKD-828
Read the detailed description
An open-label, randomized, fasted, single-dose, 2-sequence, 4-period, replicate crossover study to compare the pharmacokinetic characteristics and safety between administration of CKD-828 20/2.5mg and administration of D064, D701 in healthy adults
- Conditions
- Hypertension
- Being tested
- CKD-828, D064, D701
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-828, D064, D701Drug
QD, PO
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | * Period 1: D064, D701 - A single oral dose of 2 tablets
* Period 2: CKD-828 - A single oral dose of 1 tablet
* Period 3: D064, D701 - A single oral dose of 2 tablets
* Period 4: CKD-828 - A single oral dose of 1 tablet Receives: Drug: CKD-828, D064, D701 |
| Sequence 2 | Experimental | * Period 1: CKD-828 - A single oral dose of 1 tablet
* Period 2: D064, D701 - A single oral dose of 2 tablets
* Period 3: CKD-828 - A single oral dose of 1 tablet
* Period 4: D064, D701 - A single oral dose of 2 tablets Receives: Drug: CKD-828, D064, D701 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of CKD-828
Area under the concentration-time curve time zero to time
Measured: Pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72 hours
Cmax of CKD-828
Maximum plasma concentration of the drug
Measured: Pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 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 posted28 Apr 2023
- Study start2 May 2023
- Primary completion18 Jul 2023
- Study completion26 Jul 2023
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
- 43 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
- NCT05834595
- Sponsor's protocol ID
- A30_19BE2305
- Status last verified
- Apr 2023
- First submitted
- 18 Apr 2023
- Last updated
- 25 Aug 2023
- 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 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Fasted, Single-dose, 2-sequence, 4-period, Replicate Crossover Study to Compare the Pharmacokinetic and Safety Between Administration of CKD-828 20/2.5mg and Administration of D064, D701 in Healthy Adults
- ClinicalTrials.gov ID
- NCT05834595
- Acronym / sponsor ID
- A30_19BE2305
- Conditions
- Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 2 May 2023 (actual)
- Primary completion
- 18 Jul 2023 (actual)
- Study completion
- 26 Jul 2023 (actual)
- First posted
- 28 Apr 2023 (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 compare the pharmacokinetic and safety of CKD-828
Detailed description
An open-label, randomized, fasted, single-dose, 2-sequence, 4-period, replicate crossover study to compare the pharmacokinetic characteristics and safety between administration of CKD-828 20/2.5mg and administration of D064, D701 in healthy adults
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-828, D064, D701* Period 1: D064, D701 - A single oral dose of 2 tablets * Period 2: CKD-828 - A single oral dose of 1 tablet * Period 3: D064, D701 - A single oral dose of 2 tablets * Period 4: CKD-828 - A single oral dose of 1 tablet |
| Sequence 2 | Experimental | Drug: CKD-828, D064, D701* Period 1: CKD-828 - A single oral dose of 1 tablet * Period 2: D064, D701 - A single oral dose of 2 tablets * Period 3: CKD-828 - A single oral dose of 1 tablet * Period 4: D064, D701 - A single oral dose of 2 tablets |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy adult aged ≥ 19 at screening
- Body mass index (BMI) of 17.5 kg/m2 or more and less than 30.5kg/m2 and Body weight ≥ 55kg
- Those who do not have congenital or chronic diseases and have no pathological symptoms or findings as a result of medical examination
- A person who is deemed suitable as a subject as a result of screening such as clinical laboratory examination (hematology, blood chemistry, urinalysis, serological tests, etc.), vital signs, electrocardiogram examination, etc.
- A person who has received a sufficient explanation of the purpose and contents of the clinical trial and has agreed in writing voluntarily to participate in the clinical trial
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 on who has
- Those with a history of gastrointestinal diseases or surgery (expect 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 investigational product or bioequivalence investigational product within 6 months before the first administration of the investigational product
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-828, D064, D701QD, PO | Drug | Sequence 1, Sequence 2 |
Primary outcome
AUCt of CKD-828
Time frame: Pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72 hours
Area under the concentration-time curve time zero to time
Cmax of CKD-828
Time frame: Pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72 hours
Maximum plasma concentration of the drug
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 25 Aug 2023.
- 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.
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-828, D064, D701 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 25 Aug 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-828 (time frame: Pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 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 25 Aug 2023.