HypertensionPhase 1NCT03748212
Clinical Trial to Evaluate Pharmacokinetic Profiles and Safety Between CKD-385 and D935 in Healthy Volunteers
A Phase 1 study testing D935 Cap. 1T and CKD-385 Tab. 1T in people with Hypertension, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
A randomized, open-label, fed, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-385 in healthy volunteers Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- D935 Cap. 1T and CKD-385 Tab. 1T
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Oct 2018to Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A healthy adult aged over 19 at the time of screening
- Weight over 55, with BMI between 17.5kg/m² and 30.5kg/m²
- Subject who has no congenital or chronic disease within the last 3 years and no medical symptoms or signs as a result of medical examination
- Suitable subject who is determined at the time of screening by examiners according to the characteristics of the medicine such as hematology test, blood chemistry test, urine test, virus / bacteriological test, vital signs, electrocardiogram test
- Subject who signed the written consent form approved by Chonbuk National University Hospital IRB to participate in this study with full understanding of the purpose and contents of the examination prior to participation of the clinical trial
- Subject who has the ability and willingness to participate in the clinical trial
Who cannot join
- Subject who has (or has histories of) clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, mental, neurological or allergic diseases(except for asymptomatic seasonal allergy at the time of administration) or evidence(except for simple dental history such as dental calculus, impacted tooth, wisdom tooth, etc.)
- Subject with a history of gastrointestinal disorders(esophageal achalasia or esophagus stenosis, Crohn's disease) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery or tooth extraction surgery) that may affect the absorption of drug
- Subject who shows the following values as a result of laboratory tests
- ALT or AST > 2 times upper limit of normal range
- Subject who has a history of regular alcohol consumption in excess of 210 g/week within 6 months of screening
- Subject who smokes more than one pack of cigarette a day within 6 months of screening
Show all 18Show fewer
- Subject who took other clinical trial drugs or bioequivalence test drugs within 3 months before the first administration of clinical trial drug
- Subject who conform to the specific items below
- systolic blood pressure less than 90 mmHg, greater than 140 mmHg or diastolic blood pressure less than 60 mmHg or greater than 90 mmHg in a sitting position
- Severe bradycardia (less than 50 beats/minute)
- Subject who has significant alcohol abuse or drug abuse within a year of screening
- Subject who took drugs which are known as disturbing drug metabolism within 30 days prior to the first administration of clinical trial drug.
- Subject who uses any of other drugs, including over-the-counter medications and prescription medications within 10 days prior to first administration of clinical trial drug.
- Subject who donated whole blood within 2 months prior to first administration of clinical trial drug or blood components within 1 month prior to first administration of clinical trial drug
- Subject who is hypersensitive to the components of a clinical trial drug or clinical trial drug itself.
- Subject who does not consent to reliable contraception during the entire period of clinical trial and until 7th day of administration of clinical trial drug.
- Subject who is not able to consume high-fat meal provided during the clinical trial
- Any other subject who is decided by investigators to be ineligible in clinical trial
Trial locations and contacts
1 site in 1 country.
Min-Gul Kim contact
South Korea1 site, 1 recruiting
- Recruiting
Chonbuk National University Hospital
Jeonju
Kyung-Ho Jang, Professor
About this study
Official title: A Randomized, Open-label, Fed, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-385 in Healthy Volunteers
A randomized, open-label, fed, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-385 in healthy volunteers
Read the detailed description
To healthy subjects of 52, following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.
- Conditions
- Hypertension
- Being tested
- D935 Cap. 1T, CKD-385 Tab. 1T
- Keywords
- Hypertension, Chronic stable angina, Congestive Heart Failure
- Medical subject headings
- Hypertension, Angina, Stable, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D935 Cap. 1TDrug
Also called D935
single oral administration under fed condition
CKD-385 Tab. 1TDrug
Also called CKD-385
single oral administration under fed condition
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | D935 Cap. 1T Receives: Drug: D935 Cap. 1T |
| Group 2 | Experimental | CKD-385 Tab. 1T Receives: Drug: CKD-385 Tab. 1T |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of Carvedilol
Area under the plasma concentration of Carvedilol verses time curve from time zero to time of last quantifiable concentration
Measured: Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs
Cmax of Carvedilol
Maximum plasma concentration of Carvedilol
Measured: Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs
Secondary outcomes (5)
AUCinf of Carvedilol
Area under the plasma concentration of Carvedilol versus time curve from time zero to time infinity
Measured: Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs
Tmax of Carvedilol
Time to maximum concentration of Carvedilol
Measured: Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs
t1/2 of Carvedilol
Terminal elimination half-life of Carvedilol
Measured: Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs
CL/F of Carvedilol
Total body clearance of Carvedilol
Measured: Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs
Vd/F of Carvedilol
Apparent volume of distribution of Carvedilol
Measured: Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start24 Oct 2018
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (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
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyung-Ho Jang, Principal investigator, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748212
- Sponsor's protocol ID
- 188BE18024
- Status last verified
- Dec 2018
- First submitted
- 18 Nov 2018
- Last updated
- 31 Dec 2018
- 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 31 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Fed, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-385 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03748212
- Acronym / sponsor ID
- 188BE18024
- Conditions
- Hypertension
- Keywords
- Hypertension, Chronic stable angina, Congestive Heart Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 20 Nov 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.
A randomized, open-label, fed, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-385 in healthy volunteers
Detailed description
To healthy subjects of 52, following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: D935 Cap. 1TD935 Cap. 1T |
| Group 2 | Experimental | Drug: CKD-385 Tab. 1TCKD-385 Tab. 1T |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A healthy adult aged over 19 at the time of screening
- Weight over 55, with BMI between 17.5kg/m² and 30.5kg/m²
- Subject who has no congenital or chronic disease within the last 3 years and no medical symptoms or signs as a result of medical examination
- Suitable subject who is determined at the time of screening by examiners according to the characteristics of the medicine such as hematology test, blood chemistry test, urine test, virus / bacteriological test, vital signs, electrocardiogram test
- Subject who signed the written consent form approved by Chonbuk National University Hospital IRB to participate in this study with full understanding of the purpose and contents of the examination prior to participation of the clinical trial
Key exclusion criteria (18 listed)
- Subject who has (or has histories of) clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, mental, neurological or allergic diseases(except for asymptomatic seasonal allergy at the time of administration) or evidence(except for simple dental history such as dental calculus, impacted tooth, wisdom tooth, etc.)
- Subject with a history of gastrointestinal disorders(esophageal achalasia or esophagus stenosis, Crohn's disease) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery or tooth extraction surgery) that may affect the absorption of drug
- Subject who shows the following values as a result of laboratory tests
- ALT or AST > 2 times upper limit of normal range
- Subject who has a history of regular alcohol consumption in excess of 210 g/week within 6 months of screening
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 |
|---|---|---|
| D935 Cap. 1TAlso: D935single oral administration under fed condition | Drug | Group 1 |
| CKD-385 Tab. 1TAlso: CKD-385single oral administration under fed condition | Drug | Group 2 |
Primary outcome
AUCt of Carvedilol
Time frame: Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs
Area under the plasma concentration of Carvedilol verses time curve from time zero to time of last quantifiable concentration
Cmax of Carvedilol
Time frame: Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs
Maximum plasma concentration of Carvedilol
5 secondary outcomes
AUCinf of Carvedilol
Time frame: Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs
Tmax of Carvedilol
Time frame: Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs
t1/2 of Carvedilol
Time frame: Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs
CL/F of Carvedilol
Time frame: Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs
Vd/F of Carvedilol
Time frame: Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2018.
- 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.
Min-Gul Kim contact
Kyung-Ho Jang principal investigator
Chonbuk National University 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 D935 Cap. 1T and CKD-385 Tab. 1T in people with Hypertension, 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 6 inclusion and 18 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 31 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyung-Ho Jang (+82-63-259-3500, khjang@jbcp.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCt of Carvedilol (time frame: Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs). 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 31 Dec 2018.