HyperlipidemiasPhase 1NCT03793985
Compare the Pharmacokinetics and Safety of CKD-391 With Co-administration of D086 and D337
A Phase 1 study testing T and R in people with Hyperlipidemias, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
Compare the pharmacokinetic characteristics and safety between CKD-391 tablet and D337, D337 combination 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
- Hyperlipidemias
- What is being tested?
- T and R
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Sep 2018to 13 Nov 2018
- 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
- Between 19 aged and 45 aged in healthy male adult
- Over 50 kg, BMI between 18.0-29.0 kg/m2
- Subjects in good health as determined by physical exams and medical examinations. No congenital or chronic diseases and no abnormal signs determined by medical examinations.
- Not abnormal or not clinically significant lab values.
- Subjects who signed informed consent form with good understandings after explanations by investigators.
Who cannot join
- No history or presence of clinically significant diseases.
- Subjects showing adverse reaction to investigational product
- Genetic problems in galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
- History of myopathy
- Subjects with abnormal lab values at least one below 1) AST or ALT>2 fold of upper normal limit 2) Total bilirubin>2 fold of upper normal limit 3) CK>2 fold of upper normal limit 4) Estimated Glomerular filtration rate<60mL/min/1.73m2
- Drink over 21 units/week (1 unit= 10g=12.5mL of pure alcohol) or unable to stop drinking during clinical trials
Show all 15Show fewer
- Smoke over 10 cigarettes per day or unable to stop smoking
- Subjects who previously participated in other clinical trials within 90 days
- Subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days
- Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 10 days.
- Taking medications which induce or block medication metabolism
- History of drug abuse
- Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 7 days.
- Disagree to contraception
- Subjects who are in any conditions impossible participating in the clinical trials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-391 With Co-administration of D086 and D337 in Healthy Adult Volunteers
Compare the pharmacokinetic characteristics and safety between CKD-391 tablet and D337, D337 combination
- Conditions
- Hyperlipidemias
- Being tested
- T, R
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDrug
Also called Test Drug
CKD-391 40/10mg
RDrug
Also called Reference drug
D086 and D337 co-administration
| Study group | Role | What they receive |
|---|---|---|
| A (R+T+R+T) | Experimental | Period 1 : R Period 2 : T Period 3 : R Period 4 : T Receives: Drug: T; Drug: R |
| B (T+R+T+R) | Active comparator | Period 1 : T Period 2 : R Period 3 : T Period 4 : R Receives: Drug: T; Drug: R |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
To evaluate pharmacokinetic equivalence of experimental arm comparing Cmax
Measured: 0~72hours
AUCt
To evaluate pharmacokinetic equivalence of experimental arm comparing AUCt
Measured: 0~72hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start5 Sep 2018
- Primary completion23 Oct 2018
- Study completion13 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiasStudies 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
- 45 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
- NCT03793985
- Sponsor's protocol ID
- 152BE17006
- Status last verified
- Jan 2019
- First submitted
- 13 Dec 2018
- Last updated
- 7 Jan 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 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-391 With Co-administration of D086 and D337 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT03793985
- Acronym / sponsor ID
- 152BE17006
- Conditions
- Hyperlipidemias
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 23 Oct 2018 (actual)
- Study completion
- 13 Nov 2018 (actual)
- First posted
- 4 Jan 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.
Compare the pharmacokinetic characteristics and safety between CKD-391 tablet and D337, D337 combination
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A (R+T+R+T) | Experimental | Drug: T, Drug: RPeriod 1 : R Period 2 : T Period 3 : R Period 4 : T |
| B (T+R+T+R) | Active comparator | Drug: T, Drug: RPeriod 1 : T Period 2 : R Period 3 : T Period 4 : R |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Between 19 aged and 45 aged in healthy male adult
- Over 50 kg, BMI between 18.0-29.0 kg/m2
- Subjects in good health as determined by physical exams and medical examinations. No congenital or chronic diseases and no abnormal signs determined by medical examinations.
- Not abnormal or not clinically significant lab values.
- Subjects who signed informed consent form with good understandings after explanations by investigators.
Key exclusion criteria (15 listed)
- No history or presence of clinically significant diseases.
- Subjects showing adverse reaction to investigational product
- Genetic problems in galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
- History of myopathy
- Subjects with abnormal lab values at least one below 1) AST or ALT>2 fold of upper normal limit 2) Total bilirubin>2 fold of upper normal limit 3) CK>2 fold of upper normal limit 4) Estimated Glomerular filtration rate<60mL/min/1.73m2
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 |
|---|---|---|
| TAlso: Test DrugCKD-391 40/10mg | Drug | A (R+T+R+T), B (T+R+T+R) |
| RAlso: Reference drugD086 and D337 co-administration | Drug | A (R+T+R+T), B (T+R+T+R) |
Primary outcome
Cmax
Time frame: 0~72hours
To evaluate pharmacokinetic equivalence of experimental arm comparing Cmax
AUCt
Time frame: 0~72hours
To evaluate pharmacokinetic equivalence of experimental arm comparing AUCt
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 7 Jan 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.
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 T and R in people with Hyperlipidemias, 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 15 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 7 Jan 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?
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?
Cmax (time frame: 0~72hours). 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 7 Jan 2019.