HypertensionPhase 1NCT03659149

Pharmacokinetics and Safety Profile of CKD-333

A Phase 1 study testing CKD-333 formulation I, CKD-333 formulation II and CKD-330+D086 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

Compare the pharmacokinetic characteristics and safety between CKD-333 tablet and CKD-330, D086 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: Hypertension, Dyslipidemias
What is being tested?: CKD-333 formulation I, CKD-333 formulation II and CKD-330+D086
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 1 siteSouth Korea
Study dates: 8 Aug 2018to 12 Oct 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
Body weight more than 50kg and within ideal body weight ±20%

Who cannot join

Have clinical significant medical history or disease that cardiovascular system, respiratory system, kidney, endocrine system, hematological system, digestive system , mental illness
Have a gastrointestinal disease history that can effect drug absorption or surgery
SBP(Systolic Blood pressure)≥140mmHg or SBP<90mmHg, DBP(Diastolic Blood Pressure(≥90mmHg or DBP<60mmHg

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul Saint Mary's Hospital
Seoul

Other trials in South Korea

About this study

Official title: An Open-label, Randomized, Fasted, Single-dose, Three-way Crossover Study to Compare the Pharmacokinetics and Safety Between Administration of CKD-333 and Coadministration of CKD-330 and D086 in Healthy Male Adults

Compare the pharmacokinetic characteristics and safety between CKD-333 tablet and CKD-330, D086 combination

Read the detailed description

An open-label, randomized, fasted, single-dose, three-way crossover study to compare the pharmacokinetic characteristics and safety between administration of CKD-333 and coadministration of CKD-330 and D086 in healthy male adults

Conditions: Hypertension, Dyslipidemias
Being tested: CKD-333 formulation I, CKD-333 formulation II, CKD-330+D086
Keywords: Hypertension, Dyslipidemias, CKD-333
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-333 formulation IDrug
Also called Test drug
1 tablet administered before the breakfast(single-dose)
CKD-333 formulation IIDrug
Also called Test drug
1 tablet administered before the breakfast(single-dose)
CKD-330+D086Drug
Also called Reference drug
2 tablet administered before the breakfast(single-dose)

Study groups in NCT03659149
Study group	Role	What they receive
Group 1	Experimental	Period 1: Test drug 1(CKD-333 formulation I) Period 2: Test drug 2(CKD-333 formulation II) Period 3: Reference drug(CKD-330 + D086) Receives: Drug: CKD-333 formulation I; Drug: CKD-333 formulation II; Drug: CKD-330+D086
Group 2	Experimental	Period 1: Test drug 1(CKD-333 formulation I) Period 2: Reference drug(CKD-330 + D086) Period 3: Test drug 2(CKD-333 formulation II) Receives: Drug: CKD-333 formulation I; Drug: CKD-333 formulation II; Drug: CKD-330+D086
Group 3	Experimental	Period 1: Test drug 2(CKD-333 formulation II) Period 2: Reference drug(CKD-330 + D086) Period 3: Test drug 1(CKD-333 formulation I) Receives: Drug: CKD-333 formulation I; Drug: CKD-333 formulation II; Drug: CKD-330+D086
Group 4	Experimental	Period 1: Test drug 2(CKD-333 formulation II) Period 2: Test drug 1(CKD-333 formulation I) Period 3: Reference drug(CKD-330 + D086) Receives: Drug: CKD-333 formulation I; Drug: CKD-333 formulation II; Drug: CKD-330+D086
Group 5	Experimental	Period 1: Reference drug(CKD-330 + D086) Period 2: Test drug 1(CKD-333 formulation I) Period 3: Test drug 2(CKD-333 formulation II) Receives: Drug: CKD-333 formulation I; Drug: CKD-333 formulation II; Drug: CKD-330+D086
Group 6	Experimental	Period 1: Reference drug(CKD-330 + D086) Period 2: Test durg 2(CKD-333 formulation II) Period 3: Test drug 1(CKD-333 formulation I) Receives: Drug: CKD-333 formulation I; Drug: CKD-333 formulation II; Drug: CKD-330+D086

What is being measured

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

AUCt(Area under the plasma drug concentration-time curve) PK of Candesartan, Amlodipine, Atorvastatin
Measured: 0~72hours
Cmax(Maximum plasma concentration of the drug in plasma) of Candesartan, Amlodipine, Atorvastatin
Measured: 0~72hours

Secondary outcomes (5)

AUCinf(Area under the plasma concentration-time curve from time t to infinity) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin
Measured: 0~72hours
Tmax(Time to reach the maximum concentration) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin
Measured: 0~72hours
t1/2(Time for Cmax to drop in half) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin
Measured: 0~72hours
CL/F(Apparent clearance) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin
Measured: 0~72hours
Vd/F(Apparent volume of distribution) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin
Measured: 0~72hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Aug 201812 Oct 2018

First posted6 Sep 2018
Study start8 Aug 2018
Primary completion5 Oct 2018
Study completion12 Oct 2018

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: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03659149
Sponsor's protocol ID: 170PK18015
Status last verified: Aug 2018
First submitted: 3 Sep 2018
Last updated: 31 Oct 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Randomized, Fasted, Single-dose, Three-way Crossover Study to Compare the Pharmacokinetics and Safety Between Administration of CKD-333 and Coadministration of CKD-330 and D086 in Healthy Male Adults
ClinicalTrials.gov ID: NCT03659149
Acronym / sponsor ID: 170PK18015
Conditions: Hypertension, Dyslipidemias
Keywords: Hypertension, Dyslipidemias, CKD-333
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
Study start: 8 Aug 2018 (actual)
Primary completion: 5 Oct 2018 (actual)
Study completion: 12 Oct 2018 (actual)
First posted: 6 Sep 2018 (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-333 tablet and CKD-330, D086 combination

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Group 1	Experimental	Drug: CKD-333 formulation I, Drug: CKD-333 formulation II, Drug: CKD-330+D086Period 1: Test drug 1(CKD-333 formulation I) Period 2: Test drug 2(CKD-333 formulation II) Period 3: Reference drug(CKD-330 + D086)
Group 2	Experimental	Drug: CKD-333 formulation I, Drug: CKD-333 formulation II, Drug: CKD-330+D086Period 1: Test drug 1(CKD-333 formulation I) Period 2: Reference drug(CKD-330 + D086) Period 3: Test drug 2(CKD-333 formulation II)
Group 3	Experimental	Drug: CKD-333 formulation I, Drug: CKD-333 formulation II, Drug: CKD-330+D086Period 1: Test drug 2(CKD-333 formulation II) Period 2: Reference drug(CKD-330 + D086) Period 3: Test drug 1(CKD-333 formulation I)
Group 4	Experimental	Drug: CKD-333 formulation I, Drug: CKD-333 formulation II, Drug: CKD-330+D086Period 1: Test drug 2(CKD-333 formulation II) Period 2: Test drug 1(CKD-333 formulation I) Period 3: Reference drug(CKD-330 + D086)
Group 5	Experimental	Drug: CKD-333 formulation I, Drug: CKD-333 formulation II, Drug: CKD-330+D086Period 1: Reference drug(CKD-330 + D086) Period 2: Test drug 1(CKD-333 formulation I) Period 3: Test drug 2(CKD-333 formulation II)
Group 6	Experimental	Drug: CKD-333 formulation I, Drug: CKD-333 formulation II, Drug: CKD-330+D086Period 1: Reference drug(CKD-330 + D086) Period 2: Test durg 2(CKD-333 formulation II) Period 3: Test drug 1(CKD-333 formulation I)

Who may qualify

Ages: 19 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Between 19 aged and 45 aged in healthy male adult
Body weight more than 50kg and within ideal body weight ±20%

Key exclusion criteria (3 listed)

Have clinical significant medical history or disease that cardiovascular system, respiratory system, kidney, endocrine system, hematological system, digestive system , mental illness
Have a gastrointestinal disease history that can effect drug absorption or surgery
SBP(Systolic Blood pressure)≥140mmHg or SBP<90mmHg, DBP(Diastolic Blood Pressure(≥90mmHg or DBP<60mmHg

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-333 formulation IAlso: Test drug1 tablet administered before the breakfast(single-dose)	Drug	Group 1, Group 2, Group 3, Group 4, Group 5, Group 6
CKD-333 formulation IIAlso: Test drug1 tablet administered before the breakfast(single-dose)	Drug	Group 1, Group 2, Group 3, Group 4, Group 5, Group 6
CKD-330+D086Also: Reference drug2 tablet administered before the breakfast(single-dose)	Drug	Group 1, Group 2, Group 3, Group 4, Group 5, Group 6

Primary outcome

AUCt(Area under the plasma drug concentration-time curve) PK of Candesartan, Amlodipine, Atorvastatin
Time frame: 0~72hours
Cmax(Maximum plasma concentration of the drug in plasma) of Candesartan, Amlodipine, Atorvastatin
Time frame: 0~72hours

5 secondary outcomes

AUCinf(Area under the plasma concentration-time curve from time t to infinity) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin
Time frame: 0~72hours
Tmax(Time to reach the maximum concentration) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin
Time frame: 0~72hours
t1/2(Time for Cmax to drop in half) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin
Time frame: 0~72hours
CL/F(Apparent clearance) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin
Time frame: 0~72hours
Vd/F(Apparent volume of distribution) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin
Time frame: 0~72hours

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 31 Oct 2018.
Individual participant dataSharing planned: No

Related trials for Hypertension

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Chronic Kidney Disease, Hypertension (HTN)
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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.

Seunghun Han, Ph.D. principal investigator

Department of Clinical Pharmacology, Seoul ST.Mayr's 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-333 formulation I, CKD-333 formulation II and CKD-330+D086 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 2 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: finished, as of the sponsor's last update on 31 Oct 2018. 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(Area under the plasma drug concentration-time curve) PK of Candesartan, Amlodipine, Atorvastatin (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?

On the ClinicalTrials.gov record for NCT03659149.

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 31 Oct 2018.