HypertensionPhase 1NCT03920579
A Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-386 in Healthy Male Volunteers
A Phase 1 study testing CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337 and D013 in people with Hypertension and Dyslipidemias, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
a study to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Dyslipidemias
- What is being tested?
- CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337 and D013
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2019to May 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 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers aged between ≥20 and ≤45 years old
- Weight ≥ 50 kg, with calculated body mass index(BMI) of ≥ 18.5 and ≤ 27.0 kg/m2
- Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
- Those who are judged to be eligible for clinical trials based on laboratory and ECG results during screening tests
- Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial
Who cannot join
- History of presence of hepatobiliary, renal, cardiovascular, endocrine, respiratory, gastrointestinal, hematological, neurologic, psychiatric or musculoskeletal disorders affecting absorption, distribution, metabolism and excretion of the drug
- Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
- Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gachon University Gil Medical Center
Incheon, 21565
Dongseong Shin, M.D, Ph.D, +82-32-460-9459, dsshin@gilhospital.com
About this study
Official title: A Sequence-randomized, Open-label, 3-way Crossover, Single Oral Dose Clinical Trial to Investigate the Pharmacokinetic Characteristics and Safety/Tolerability According to Formulations of CKD-386 in Healthy Male Volunteers
a study to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers
Read the detailed description
A sequence-randomized, open-label, 3-way crossover, single oral dose clinical trial to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers
- Conditions
- Hypertension, Dyslipidemias
- Being tested
- CKD-386 formulation 1, CKD-386 formulation 2, D326, D337 and D013
- Keywords
- CKD-386, Pharmacokinetics, D326, D337, D013
- Medical subject headings
- Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-386 formulation 1Drug
Also called CKD-386 Test 1
A single oral dose of 1 tablet under fasting conditions for each period
CKD-386 formulation 2Drug
Also called CKD-386 Test 2
A single oral dose of 1 tablet under fasting conditions for each period
D326, D337 and D013Drug
Also called CKD-386 Reference
A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Period 1: CKD-386 formulation 1(1 tab, once) / Period 2: CKD-386 formulation 2(1 tab, once) / Period 3: D326, D337, D013(3 tabs, once) Receives: Drug: CKD-386 formulation 1; Drug: CKD-386 formulation 2; Drug: D326, D337 and D013 |
| Sequence 2 | Experimental | Period 1: CKD-386 formulation 1(1 tab, once) / Period 2: D326, D337, D013(3 tabs, once) / Period 3: CKD-386 formulation 2(1 tab, once) Receives: Drug: CKD-386 formulation 1; Drug: CKD-386 formulation 2; Drug: D326, D337 and D013 |
| Sequence 3 | Experimental | Period 1: CKD-386 formulation 2(1 tab, once) / Period 2: D326, D337, D013(3 tabs, once) / Period 3: CKD-386 formulation 1(1 tab, once) Receives: Drug: CKD-386 formulation 1; Drug: CKD-386 formulation 2; Drug: D326, D337 and D013 |
| Sequence 4 | Experimental | Period 1: CKD-386 formulation 2(1 tab, once) / Period 2: CKD-386 formulation 1(1 tab, once) / Period 3: D326, D337, D013 Receives: Drug: CKD-386 formulation 1; Drug: CKD-386 formulation 2; Drug: D326, D337 and D013 |
| Sequence 5 | Experimental | Period 1: D326, D337, D013(3 tabs, once) / Period 2: CKD-386 formulation 1(1 tab, once) / Period 3: CKD-386 formulation 2(1 tab, once) Receives: Drug: CKD-386 formulation 1; Drug: CKD-386 formulation 2; Drug: D326, D337 and D013 |
| Sequence 6 | Experimental | Period 1: D326, D337, D013 (3 tabs, once)/ Period 2: CKD-386 formulation 2(1 tab, once) / Period 3: CKD-386 formulation 1(1 tab, once) Receives: Drug: CKD-386 formulation 1; Drug: CKD-386 formulation 2; Drug: D326, D337 and D013 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013
AUC0-t: Area under the concentration-time curve from time zero to time
Measured: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Cmax of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013
Cmax: Maximum plasma concentration of the drug
Measured: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Secondary outcomes (7)
AUCinf each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
AUCinf: Area under the concentration-time curve from zero up to ∞
Measured: 0(predose)~72 hour at Day1~D3, Day15~D17, Day29~31
Tmax of each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Tmax: Time to maximum plasma concentration
Measured: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
t1/2 of each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
t1/2: Terminal elimination half-life
Measured: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
CL/F of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
CL/F: Apparent total body clearance of the drug
Measured: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Vd/F of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Vd/F: Apparent volume of distribution
Measured: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
AUC0-t of the metabolite of each component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
AUC0-t: Area under the concentration-time curve from time zero to time
Measured: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Cmax of the metabolite of each component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Cmax: Maximum plasma concentration of the drug
Measured: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start1 Apr 2019
- Primary completionMay 2019 (estimated)
- Study completionMay 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dongseong Shin, M.D, Ph.D, Principal investigator, Clinical Trials Center, Gil Medical Center, Incheon, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920579
- Sponsor's protocol ID
- 183PK18034
- Status last verified
- Apr 2019
- First submitted
- 8 Apr 2019
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- 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 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sequence-randomized, Open-label, 3-way Crossover, Single Oral Dose Clinical Trial to Investigate the Pharmacokinetic Characteristics and Safety/Tolerability According to Formulations of CKD-386 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03920579
- Acronym / sponsor ID
- 183PK18034
- Conditions
- Hypertension, Dyslipidemias
- Keywords
- CKD-386, Pharmacokinetics, D326, D337, D013
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 19 Apr 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 study to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers
Detailed description
A sequence-randomized, open-label, 3-way crossover, single oral dose clinical trial to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers
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-386 formulation 1, Drug: CKD-386 formulation 2, Drug: D326, D337 and D013Period 1: CKD-386 formulation 1(1 tab, once) / Period 2: CKD-386 formulation 2(1 tab, once) / Period 3: D326, D337, D013(3 tabs, once) |
| Sequence 2 | Experimental | Drug: CKD-386 formulation 1, Drug: CKD-386 formulation 2, Drug: D326, D337 and D013Period 1: CKD-386 formulation 1(1 tab, once) / Period 2: D326, D337, D013(3 tabs, once) / Period 3: CKD-386 formulation 2(1 tab, once) |
| Sequence 3 | Experimental | Drug: CKD-386 formulation 1, Drug: CKD-386 formulation 2, Drug: D326, D337 and D013Period 1: CKD-386 formulation 2(1 tab, once) / Period 2: D326, D337, D013(3 tabs, once) / Period 3: CKD-386 formulation 1(1 tab, once) |
| Sequence 4 | Experimental | Drug: CKD-386 formulation 1, Drug: CKD-386 formulation 2, Drug: D326, D337 and D013Period 1: CKD-386 formulation 2(1 tab, once) / Period 2: CKD-386 formulation 1(1 tab, once) / Period 3: D326, D337, D013 |
| Sequence 5 | Experimental | Drug: CKD-386 formulation 1, Drug: CKD-386 formulation 2, Drug: D326, D337 and D013Period 1: D326, D337, D013(3 tabs, once) / Period 2: CKD-386 formulation 1(1 tab, once) / Period 3: CKD-386 formulation 2(1 tab, once) |
| Sequence 6 | Experimental | Drug: CKD-386 formulation 1, Drug: CKD-386 formulation 2, Drug: D326, D337 and D013Period 1: D326, D337, D013 (3 tabs, once)/ Period 2: CKD-386 formulation 2(1 tab, once) / Period 3: CKD-386 formulation 1(1 tab, once) |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy volunteers aged between ≥20 and ≤45 years old
- Weight ≥ 50 kg, with calculated body mass index(BMI) of ≥ 18.5 and ≤ 27.0 kg/m2
- Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
- Those who are judged to be eligible for clinical trials based on laboratory and ECG results during screening tests
- Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial
Key exclusion criteria (3 listed)
- History of presence of hepatobiliary, renal, cardiovascular, endocrine, respiratory, gastrointestinal, hematological, neurologic, psychiatric or musculoskeletal disorders affecting absorption, distribution, metabolism and excretion of the drug
- Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
- Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests
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-386 formulation 1Also: CKD-386 Test 1A single oral dose of 1 tablet under fasting conditions for each period | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| CKD-386 formulation 2Also: CKD-386 Test 2A single oral dose of 1 tablet under fasting conditions for each period | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| D326, D337 and D013Also: CKD-386 ReferenceA single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
Primary outcome
AUC0-t of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013
Time frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
AUC0-t: Area under the concentration-time curve from time zero to time
Cmax of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013
Time frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Cmax: Maximum plasma concentration of the drug
7 secondary outcomes
AUCinf each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Time frame: 0(predose)~72 hour at Day1~D3, Day15~D17, Day29~31
Tmax of each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Time frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
t1/2 of each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Time frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
CL/F of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Time frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Vd/F of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Time frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
AUC0-t of the metabolite of each component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Time frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Cmax of the metabolite of each component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Time frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- 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.
Dongseong Shin, M.D, Ph.D principal investigator
Clinical Trials Center, Gil Medical Center, Incheon, Korea
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-386 formulation 1, CKD-386 formulation 2 and D326, D337 and D013 in people with Hypertension and Dyslipidemias, 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 5 inclusion and 3 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 19 Apr 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dongseong Shin, M.D, Ph.D (+82-32-460-9459, dsshin@gilhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-t of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013 (time frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31). 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 19 Apr 2019.