HypertensionPhase 1CKD-348NCT04258865

A Clinical Trial to Compare the Pharmacokinetics and Tolerability of CKD-348

A Phase 1 study testing CKD-348 F1, CKD-348 F2 and CKD-828, D097, D337 in people with Hypertension and Dyslipidemias, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A clinical trial to compare the pharmacokinetics and tolerability of CKD-348 Read more about this study

Who is it for?: Ages 19 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Hypertension, Dyslipidemias
What is being tested?: CKD-348 F1, CKD-348 F2 and CKD-828, D097, D337
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: 25 Mar 2020to 13 May 2020
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy adult volunteers aged ≥ 19-year-old
Weight ≥ 50kg (man) or 45kg (woman), with calculated body mass index(BMI) of 18 to 30 kg/m2
Those who are eligible for adequate blood pressure criteria during screening tests Systolic blood pressure: 90 to 139 mmHg Diastolic blood pressure: 60 to 89 mmHg
Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests
Those who agree to contraception during the participation of clinical trial
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

Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug
Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of clinical trial drug
Those who donated whole blood and apheresis within 2 months or received transfusion within 1 month
Those who has a history of gastrointestinal surgery (
Those who exceeding an alcohol and smoke consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, Beer 250mL, Wine 30mL) Smoke: 20 cigarettes/day
Those who has a disease history of diabetic mellitus, nephropathy, biliary obstruction, shock, dihydropyridine sensitivity, angioedema, cardiac insufficiency

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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
Women who are pregnant or who may be pregnant and breastfeed

Trial locations and contacts

1 site in 1 country.

South Korea1 site

H Plus Yangji Hospital
Seoul, Gwanak-gu, 08779

Other trials in South Korea

About this study

Official title: Phase I Clinical Trial to Compare the Pharmacokinetics and Tolerability of CKD-348 With Co-administration of CKD-828, D097 and D337 in Healthy Adult Volunteers

A clinical trial to compare the pharmacokinetics and tolerability of CKD-348

Read the detailed description

A randomized, open-label, single-dose, 3-way crossover clinical trial to compare the pharmacokinetics and tolerability of CKD-348 with co-administrated drugs in healthy adult volunteers

Conditions: Hypertension, Dyslipidemias
Being tested: CKD-348 F1, CKD-348 F2, CKD-828, D097, D337
Keywords: CKD-348
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-348 F1Drug
QD, PO
CKD-348 F2Drug
QD, PO
CKD-828, D097, D337Drug
QD, PO

Study groups in NCT04258865
Study group	Role	What they receive
Sequence 1	Experimental	Period 1: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Period 2: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Receives: Drug: CKD-348 F1; Drug: CKD-348 F2; Drug: CKD-828, D097, D337
Sequence 2	Experimental	Period 1: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Period 2: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Receives: Drug: CKD-348 F1; Drug: CKD-348 F2; Drug: CKD-828, D097, D337
Sequence 3	Experimental	Period 1: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Period 3: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Receives: Drug: CKD-348 F1; Drug: CKD-348 F2; Drug: CKD-828, D097, D337
Sequence 4	Experimental	Period 1: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Receives: Drug: CKD-348 F1; Drug: CKD-348 F2; Drug: CKD-828, D097, D337
Sequence 5	Experimental	Period 1: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Period 3: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Receives: Drug: CKD-348 F1; Drug: CKD-348 F2; Drug: CKD-828, D097, D337
Sequence 6	Experimental	Period 1: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Receives: Drug: CKD-348 F1; Drug: CKD-348 F2; Drug: CKD-828, D097, D337

What is being measured

The primary outcome is the main question the study is designed to answer.

AUCt of CKD-348
AUCt: Area under the concentration-time curve from 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, 10, 12, 24, 48, 72 hours
Cmax of CKD-348
Cmax: 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, 10, 12, 24, 48, 72 hours

Secondary outcomes (4)

AUCinf of CKD-348
AUCinf: Area under the concentration-time curve from zero up to ∞
Measured: Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Tmax of CKD-348
Tmax: Time to maximum plasma concentration
Measured: Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
t1/2 of CKD-348
t1/2: Terminal elimination half-life
Measured: Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
AUCt/AUCinf of CKD-348
AUCt/AUCinf
Measured: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 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.

25 Mar 202013 May 2020

First posted6 Feb 2020
Study start25 Mar 2020
Primary completion26 Apr 2020
Study completion13 May 2020

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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04258865
Sponsor's protocol ID: A86_05BE1916P
Acronym: CKD-348
Status last verified: Jun 2020
First submitted: 5 Feb 2020
Last updated: 5 Jun 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Clinical Trial to Compare the Pharmacokinetics and Tolerability of CKD-348 With Co-administration of CKD-828, D097 and D337 in Healthy Adult Volunteers
ClinicalTrials.gov ID: NCT04258865
Acronym / sponsor ID: CKD-348 / A86_05BE1916P
Conditions: Hypertension, Dyslipidemias
Keywords: CKD-348
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
Study start: 25 Mar 2020 (actual)
Primary completion: 26 Apr 2020 (actual)
Study completion: 13 May 2020 (actual)
First posted: 6 Feb 2020 (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 pharmacokinetics and tolerability of CKD-348

Detailed description

A randomized, open-label, single-dose, 3-way crossover clinical trial to compare the pharmacokinetics and tolerability of CKD-348 with co-administrated drugs in healthy adult 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-348 F1, Drug: CKD-348 F2, Drug: CKD-828, D097, D337Period 1: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Period 2: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions
Sequence 2	Experimental	Drug: CKD-348 F1, Drug: CKD-348 F2, Drug: CKD-828, D097, D337Period 1: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Period 2: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions
Sequence 3	Experimental	Drug: CKD-348 F1, Drug: CKD-348 F2, Drug: CKD-828, D097, D337Period 1: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Period 3: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions
Sequence 4	Experimental	Drug: CKD-348 F1, Drug: CKD-348 F2, Drug: CKD-828, D097, D337Period 1: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions
Sequence 5	Experimental	Drug: CKD-348 F1, Drug: CKD-348 F2, Drug: CKD-828, D097, D337Period 1: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Period 3: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions
Sequence 6	Experimental	Drug: CKD-348 F1, Drug: CKD-348 F2, Drug: CKD-828, D097, D337Period 1: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions

Who may qualify

Ages: 19 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Healthy adult volunteers aged ≥ 19-year-old
Weight ≥ 50kg (man) or 45kg (woman), with calculated body mass index(BMI) of 18 to 30 kg/m2
Those who are eligible for adequate blood pressure criteria during screening tests Systolic blood pressure: 90 to 139 mmHg Diastolic blood pressure: 60 to 89 mmHg
Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests

Key exclusion criteria (9 listed)

Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug
Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of clinical trial drug
Those who donated whole blood and apheresis within 2 months or received transfusion within 1 month
Those who has a history of gastrointestinal surgery (
Those who exceeding an alcohol and smoke consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, Beer 250mL, Wine 30mL) Smoke: 20 cigarettes/day

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-348 F1QD, PO	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6
CKD-348 F2QD, PO	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6
CKD-828, D097, D337QD, PO	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6

Primary outcome

AUCt of CKD-348
Time frame: Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
AUCt: Area under the concentration-time curve from time zero to time
Cmax of CKD-348
Time frame: Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Cmax: Maximum plasma concentration of the drug

4 secondary outcomes

AUCinf of CKD-348
Time frame: Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Tmax of CKD-348
Time frame: Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
t1/2 of CKD-348
Time frame: Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
AUCt/AUCinf of CKD-348
Time frame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours

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 5 Jun 2020.

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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.

Yook-Hwan Noh, M.D., PhD. principal investigator

H Plus Yangji Hospital

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-348 F1, CKD-348 F2 and CKD-828, D097, D337 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 7 inclusion and 9 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 5 Jun 2020. 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-348 (time frame: Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 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?

On the ClinicalTrials.gov record for NCT04258865.

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 5 Jun 2020.