HypertensionPhase 1NCT03849287
Compare the Pharmacokinetics and Safety of CKD-333 With Co-administration CKD-330 and D090 in Healthy Male Adults
A Phase 1 study testing CKD-333, formula I, CKD-333, formula II and CKD-330, D090 in people with Hypertension and Dyslipidemias, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
The object of clinical trial is to investigate the pharmacokinetics and safety compared to CKD-333 and co-administration CKD-330, D090 under fasting condition in healthy male adults. 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, formula I, CKD-333, formula II and CKD-330, D090
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Feb 2019to 6 Apr 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 male adults aged 19 to 45 years
- Body weight more than 50kg and within ideal body weight ±20%
- signed informed consent form
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
- Systolic Blood pressure≥140mmHg or Systolic Blood pressure<90mmHg, Diastolic Blood Pressure≥90mmHg or Diastolic Blood Pressure<60mmHg
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul Saint Mary's Hospital
Seoul
Seunghun Han, Ph.D., +82-2-2258-7326
About this study
Official title: 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 D090 in Healthy Male Adults
The object of clinical trial is to investigate the pharmacokinetics and safety compared to CKD-333 and co-administration CKD-330, D090 under fasting condition in healthy male adults.
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 D090 in healthy male adults
- Conditions
- Hypertension, Dyslipidemias
- Being tested
- CKD-333, formula I, CKD-333, formula II, CKD-330, D090
- 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, formula IDrug
Test drug
CKD-333, formula IIDrug
Test drug
CKD-330, D090Drug
Reference Drug
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | * Period 1: CKD-333, formula I
* Period 2: CKD-333, formula II
* Period 3: CKD-330, D090 Receives: Drug: CKD-333, formula I; Drug: CKD-333, formula II; Drug: CKD-330, D090 |
| Group 2 | Experimental | * Period 1: CKD-333, formula I
* Period 2: CKD-330, D090
* Period 3: CKD-333, formula II Receives: Drug: CKD-333, formula I; Drug: CKD-333, formula II; Drug: CKD-330, D090 |
| Group 3 | Experimental | * Period 1: CKD-333, formula II
* Period 2: CKD-330, D090
* Period 3: CKD-333, formula I Receives: Drug: CKD-333, formula I; Drug: CKD-333, formula II; Drug: CKD-330, D090 |
| Group 4 | Experimental | * Period 1: CKD-333, formula II
* Period 2: CKD-333, formula I
* Period 3: CKD-330, D090 Receives: Drug: CKD-333, formula I; Drug: CKD-333, formula II; Drug: CKD-330, D090 |
| Group 5 | Experimental | * Period 1: CKD-330, D090
* Period 2: CKD-333, formula I
* Period 3: CKD-333, formula II Receives: Drug: CKD-333, formula I; Drug: CKD-333, formula II; Drug: CKD-330, D090 |
| Group 6 | Experimental | * Period 1: CKD-330, D090
* Period 2: CKD-333, formula II
* Period 3: CKD-333, formula I Receives: Drug: CKD-333, formula I; Drug: CKD-333, formula II; Drug: CKD-330, D090 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast of Candesartan
Area under the plasma concentration-time curve to last concentration of Candesartan
Measured: 0 hour ~ 72 hour after drug administration
AUClast of Amlodipine
Area under the plasma concentration-time curve to last concentration of Amlodipine
Measured: 0 hour ~ 72 hour after drug administration
AUClast of Atorvastatin
Area under the plasma concentration-time curve to last concentration of Atorvastatin
Measured: 0 hour ~ 72 hour after drug administration
Cmax of Candesartan
Maximum plasma concentration of Candesartan
Measured: 0 hour ~ 72 hour after drug administration
Cmax of Amlodipine
Maximum plasma concentration of Amlodipine
Measured: 0 hour ~ 72 hour after drug administration
Cmax of Atorvastatin
Maximum plasma concentration of Atorvastatin
Measured: 0 hour ~ 72 hour after drug administration
Secondary outcomes (20)
AUCinf of Candesartan
Area under the plasma concentration-time curve from zero to infinity concentration of Candesartan
Measured: 0 hour ~ 72 hour after drug administration
AUCinf of Amlodipine
Area under the plasma concentration-time curve from zero to infinity concentration of Amlodipine
Measured: 0 hour ~ 72 hour after drug administration
AUCinf of Atorvastatin
Area under the plasma concentration-time curve from zero to infinity concentration of Atorvastatin
Measured: 0 hour ~ 72 hour after drug administration
AUCinf of 2-hydroxy atorvastatin
Area under the plasma concentration-time curve from zero to infinity concentration of 2-hydroxy atorvastatin
Measured: 0 hour ~ 72 hour after drug administration
Tmax of Candesartan
Time to maximum plasma concentration of Candesartan
Measured: 0 hour ~ 72 hour after drug administration
Tmax of Amlodipine
Time to maximum plasma concentration of Amlodipine
Measured: 0 hour ~ 72 hour after drug administration
Tmax of Atorvastatin
Time to maximum plasma concentration of Atorvastatin
Measured: 0 hour ~ 72 hour after drug administration
Tmax of 2-hydroxy atorvastatin
Time to maximum plasma concentration of 2-hydroxy atorvastatin
Measured: 0 hour ~ 72 hour after drug administration
T1/2 of Candesartan
Half-life of Candesartan
Measured: 0 hour ~ 72 hour after drug administration
T1/2 of Amlodipine
Half-life of Amlodipine
Measured: 0 hour ~ 72 hour after drug administration
T1/2 of Atorvastatin
Half-life of Atorvastatin
Measured: 0 hour ~ 72 hour after drug administration
T1/2 of 2-hydroxy atorvastatin
Half-life of 2-hydroxy atorvastatin
Measured: 0 hour ~ 72 hour after drug administration
clearance of Candesartan
Apparent clearance of Candesartan
Measured: 0 hour ~ 72 hour after drug administration
clearance of Amlodipine
Apparent clearance of Amlodipine
Measured: 0 hour ~ 72 hour after drug administration
clearance of Atorvastatin
Apparent clearance of Atorvastatin
Measured: 0 hour ~ 72 hour after drug administration
clearance of 2-hydroxy atorvastatin
Apparent clearance of 2-hydroxy atorvastatin
Measured: 0 hour ~ 72 hour after drug administration
Vd/F of Candesartan
Apparent volume of distribution of Candesartan
Measured: 0 hour ~ 72 hour after drug administration
Vd/F of Amlodipine
Apparent volume of distribution of Amlodipine
Measured: 0 hour ~ 72 hour after drug administration
Vd/F of Atorvastatin
Apparent volume of distribution of Atorvastatin
Measured: 0 hour ~ 72 hour after drug administration
Vd/F of 2-hydroxy atorvastatin
Apparent volume of distribution of 2-hydroxy atorvastatin
Measured: 0 hour ~ 72 hour after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start25 Feb 2019 (estimated)
- Primary completion29 Mar 2019 (estimated)
- Study completion6 Apr 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seunghun Han, Ph.D., Principal investigator, Department of Clinical Pharmacology, Seoul ST.Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849287
- Sponsor's protocol ID
- 170PK18039
- Status last verified
- Feb 2019
- First submitted
- 20 Feb 2019
- Last updated
- 22 Feb 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 22 Feb 2019. 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 Pharmacokinetic Characteristics and Safety Between Administration of CKD-333 and Coadministration of CKD-330 and D090 in Healthy Male Adults
- ClinicalTrials.gov ID
- NCT03849287
- Acronym / sponsor ID
- 170PK18039
- Conditions
- Hypertension, Dyslipidemias
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2019 (estimated)
- Primary completion
- 29 Mar 2019 (estimated)
- Study completion
- 6 Apr 2019 (estimated)
- First posted
- 21 Feb 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.
The object of clinical trial is to investigate the pharmacokinetics and safety compared to CKD-333 and co-administration CKD-330, D090 under fasting condition in healthy male adults.
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 D090 in healthy male adults
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, formula I, Drug: CKD-333, formula II, Drug: CKD-330, D090* Period 1: CKD-333, formula I * Period 2: CKD-333, formula II * Period 3: CKD-330, D090 |
| Group 2 | Experimental | Drug: CKD-333, formula I, Drug: CKD-333, formula II, Drug: CKD-330, D090* Period 1: CKD-333, formula I * Period 2: CKD-330, D090 * Period 3: CKD-333, formula II |
| Group 3 | Experimental | Drug: CKD-333, formula I, Drug: CKD-333, formula II, Drug: CKD-330, D090* Period 1: CKD-333, formula II * Period 2: CKD-330, D090 * Period 3: CKD-333, formula I |
| Group 4 | Experimental | Drug: CKD-333, formula I, Drug: CKD-333, formula II, Drug: CKD-330, D090* Period 1: CKD-333, formula II * Period 2: CKD-333, formula I * Period 3: CKD-330, D090 |
| Group 5 | Experimental | Drug: CKD-333, formula I, Drug: CKD-333, formula II, Drug: CKD-330, D090* Period 1: CKD-330, D090 * Period 2: CKD-333, formula I * Period 3: CKD-333, formula II |
| Group 6 | Experimental | Drug: CKD-333, formula I, Drug: CKD-333, formula II, Drug: CKD-330, D090* Period 1: CKD-330, D090 * Period 2: CKD-333, formula II * Period 3: CKD-333, formula I |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male adults aged 19 to 45 years
- Body weight more than 50kg and within ideal body weight ±20%
- signed informed consent form
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
- Systolic Blood pressure≥140mmHg or Systolic Blood pressure<90mmHg, Diastolic Blood Pressure≥90mmHg or Diastolic Blood Pressure<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, formula ITest drug | Drug | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
| CKD-333, formula IITest drug | Drug | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
| CKD-330, D090Reference Drug | Drug | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
Primary outcome
AUClast of Candesartan
Time frame: 0 hour ~ 72 hour after drug administration
Area under the plasma concentration-time curve to last concentration of Candesartan
AUClast of Amlodipine
Time frame: 0 hour ~ 72 hour after drug administration
Area under the plasma concentration-time curve to last concentration of Amlodipine
AUClast of Atorvastatin
Time frame: 0 hour ~ 72 hour after drug administration
Area under the plasma concentration-time curve to last concentration of Atorvastatin
Cmax of Candesartan
Time frame: 0 hour ~ 72 hour after drug administration
Maximum plasma concentration of Candesartan
Cmax of Amlodipine
Time frame: 0 hour ~ 72 hour after drug administration
Maximum plasma concentration of Amlodipine
Cmax of Atorvastatin
Time frame: 0 hour ~ 72 hour after drug administration
Maximum plasma concentration of Atorvastatin
20 secondary outcomes
AUCinf of Candesartan
Time frame: 0 hour ~ 72 hour after drug administration
AUCinf of Amlodipine
Time frame: 0 hour ~ 72 hour after drug administration
AUCinf of Atorvastatin
Time frame: 0 hour ~ 72 hour after drug administration
AUCinf of 2-hydroxy atorvastatin
Time frame: 0 hour ~ 72 hour after drug administration
Tmax of Candesartan
Time frame: 0 hour ~ 72 hour after drug administration
Tmax of Amlodipine
Time frame: 0 hour ~ 72 hour after drug administration
Tmax of Atorvastatin
Time frame: 0 hour ~ 72 hour after drug administration
Tmax of 2-hydroxy atorvastatin
Time frame: 0 hour ~ 72 hour after drug administration
T1/2 of Candesartan
Time frame: 0 hour ~ 72 hour after drug administration
T1/2 of Amlodipine
Time frame: 0 hour ~ 72 hour after drug administration
T1/2 of Atorvastatin
Time frame: 0 hour ~ 72 hour after drug administration
T1/2 of 2-hydroxy atorvastatin
Time frame: 0 hour ~ 72 hour after drug administration
clearance of Candesartan
Time frame: 0 hour ~ 72 hour after drug administration
clearance of Amlodipine
Time frame: 0 hour ~ 72 hour after drug administration
clearance of Atorvastatin
Time frame: 0 hour ~ 72 hour after drug administration
clearance of 2-hydroxy atorvastatin
Time frame: 0 hour ~ 72 hour after drug administration
Vd/F of Candesartan
Time frame: 0 hour ~ 72 hour after drug administration
Vd/F of Amlodipine
Time frame: 0 hour ~ 72 hour after drug administration
Vd/F of Atorvastatin
Time frame: 0 hour ~ 72 hour after drug administration
Vd/F of 2-hydroxy atorvastatin
Time frame: 0 hour ~ 72 hour after drug administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.Mary'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, formula I, CKD-333, formula II and CKD-330, D090 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 3 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 22 Feb 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 Seunghun Han, Ph.D. (+82-2-2258-7326, waystolove@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUClast of Candesartan (time frame: 0 hour ~ 72 hour after drug administration). The study lists 6 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 22 Feb 2019.