HypertensionPhase 1NCT04035538
A Clinical Study to Compare the Safety and Pharmacokinetics of CKD-320 and D012
A Phase 1 study testing CKD-320, D012 in people with Hypertension, run by Chong Kun Dang Pharmaceutical.
Trial summary
A clinical study to compare the safety and pharmacokinetics of CKD-320 and D012 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-320, D012
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Aug 2019to Dec 2019
- 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 older than 19 years at the time of screening
- Body weight more than 55kg and within ±20% of the calculated ideal body weight(IBW = (height -100) x 0.9)
- No congenital or chronic disease and no pathological symptoms or findings
- Suitable subject who is determined to be suitable in laboratory testing such as hematology, blood chemistry, urinalysis and 12-lead electrocardiogram
- Subject who have received a detailed explanation of this clinical trial and have fully understood it, and agree in writing to comply
Who cannot join
- Subject who has a history of clinical significant hepatobiliary, kidney, digestive, respiratory, blood-oncology, endocrine, urinary, psychiatric, musculoskeletal, immune, acute and unstable heart failure or evidence
- Subject with a history of gastrointestinal disorders(Crohn's disease, ulcer, acute or chronic pancreatitis) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery) that may affect the absorption
- A hereditary angioedema patient, with a history angioedema, or hereditary fructose patient
- Clinical laboratory test results showing the following values
- ALT or AST > 2 times upper limit of normal range
- eGFR < 60mL/min/1.73m2
Show all 20Show fewer
- Subject with a history of overreaction or clinical significant hypersensitivity to drugs
- Subject who has a systolic blood pressure > 140mmHg or < 100mmHg, diastolic blood pressure > 90mmHg or < 60mmHg, pulses ≥ 100 per minutes
- In case of past history of drug abuse or positive for urine test of drug abuse
- Those taking medication known to significantly induce or inhibit drug metabolizing enzymes within 30days before the first administration of clinical trial drug
- Those taking prescription drugs, natural drug(ex, St. John's wort), herbal medicine within 14days and non-prescription drugs or vitamin supplements within 7days before the first administration of clinical trial drug
- Those taking other clinical trial drugs or bioequivalence test drugs within 6months before the first administration of clinical trial drug
- Those who donated whole blood within 2 months or those who donated the components within 1 month or blood transfusion within 1 month before the first administration of the clinical trial drug
- Subject who has a history of regular alcohol consumption exceeding 210g/week within 6months of screening (1 glass of beer(5%)=10g, 1 glass of soju(20%)=8g, 1 glass of wine(12%)=12g)
- > 10 smokers per day within 3months of screening and those who can't quit smoking
- Blood test(RPR Ab, HBS Ag, HCV Ab, anti HIV(AIDS)) results indicate a positive
- Subject who can't comply with the lifestyle guidelines
- A pregnant(a likely), breastfeeding women
- Subject who don't agree or can't comply reliable contraception from screening to 14days after the last drug administration
- Subject who is judged by the investigator principal to be ineligible to participate in the clinical trial
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Open-label, Single-dose, Replicate-crossover Study to Compare the Safety and Pharmacokinetics of CKD-320 and D012 in Healthy Subjects
A clinical study to compare the safety and pharmacokinetics of CKD-320 and D012
Read the detailed description
A randomized, open-label, single-dose, replicate-crossover study to compare the safety and pharmacokinetics of CKD-320 and D012 in healthy subjects
- Conditions
- Hypertension
- Being tested
- CKD-320, D012
- Keywords
- CKD-320
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-320, D012Drug
R: D012 1tablet, QD, PO T: CKD-320 2tablets, QD, PO
| Study group | Role | What they receive |
|---|---|---|
| A group | Experimental | Not described Receives: Drug: CKD-320, D012 |
| B group | Experimental | Not described Receives: Drug: CKD-320, D012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of CKD-320
Measured: predose(0 hour), 0.17, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours
Cmax of CKD-320
Measured: predose(0 hour), 0.17, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours
Secondary outcomes (4)
Tmax of CKD-320
Measured: predose(0 hour), 0.17, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours
t1/2 of CKD-320
Measured: predose(0 hour), 0.17, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours
AUCinf of CKD-320
Measured: predose(0 hour), 0.17, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours
AUCt/AUCinf of CKD-320
Measured: predose(0 hour), 0.17, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 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 posted29 Jul 2019
- Study startAug 2019 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionDec 2019 (estimated)
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
- 42 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
- NCT04035538
- Sponsor's protocol ID
- A94_01BE1909
- Status last verified
- Jul 2019
- First submitted
- 25 Jul 2019
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, Replicate-crossover Study to Compare the Safety and Pharmacokinetics of CKD-320 and D012 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04035538
- Acronym / sponsor ID
- A94_01BE1909
- Conditions
- Hypertension
- Keywords
- CKD-320
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Aug 2019 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 29 Jul 2019 (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 study to compare the safety and pharmacokinetics of CKD-320 and D012
Detailed description
A randomized, open-label, single-dose, replicate-crossover study to compare the safety and pharmacokinetics of CKD-320 and D012 in healthy subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A group | Experimental | Drug: CKD-320, D012 |
| B group | Experimental | Drug: CKD-320, D012 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy adult older than 19 years at the time of screening
- Body weight more than 55kg and within ±20% of the calculated ideal body weight(IBW = (height -100) x 0.9)
- No congenital or chronic disease and no pathological symptoms or findings
- Suitable subject who is determined to be suitable in laboratory testing such as hematology, blood chemistry, urinalysis and 12-lead electrocardiogram
- Subject who have received a detailed explanation of this clinical trial and have fully understood it, and agree in writing to comply
Key exclusion criteria (20 listed)
- Subject who has a history of clinical significant hepatobiliary, kidney, digestive, respiratory, blood-oncology, endocrine, urinary, psychiatric, musculoskeletal, immune, acute and unstable heart failure or evidence
- Subject with a history of gastrointestinal disorders(Crohn's disease, ulcer, acute or chronic pancreatitis) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery) that may affect the absorption
- A hereditary angioedema patient, with a history angioedema, or hereditary fructose patient
- Clinical laboratory test results showing the following values
- Subject with a history of overreaction or clinical significant hypersensitivity to drugs
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-320, D012R: D012 1tablet, QD, PO T: CKD-320 2tablets, QD, PO | Drug | A group, B group |
Primary outcome
AUCt of CKD-320
Time frame: predose(0 hour), 0.17, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours
Cmax of CKD-320
Time frame: predose(0 hour), 0.17, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours
4 secondary outcomes
Tmax of CKD-320
Time frame: predose(0 hour), 0.17, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours
t1/2 of CKD-320
Time frame: predose(0 hour), 0.17, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours
AUCinf of CKD-320
Time frame: predose(0 hour), 0.17, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours
AUCt/AUCinf of CKD-320
Time frame: predose(0 hour), 0.17, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CKD-320, D012 in people with Hypertension, 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 5 inclusion and 20 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 29 Jul 2019. 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 Jang-Hee Hong (+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-320 (time frame: predose(0 hour), 0.17, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 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 29 Jul 2019.