DyslipidemiasPhase 1NCT05259020
To Evaluate the Pharmacokinetics and the Safety of ID14009 Compared to Coadministration of ID1805 With ID1803 in Healthy Adult Volunteers
A Phase 1 study testing ID140009 and ID1803+ID1805 in people with Dyslipidemias and Hypertension, run by IlDong Pharmaceutical Co Ltd at 1 site in South Korea.
Trial summary
To evaluate the pharmacokinetics and the safety of ID14009 compared to coadministration of ID1805 with ID1803 in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias, Hypertension
- What is being tested?
- ID140009 and ID1803+ID1805
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Feb 2022to 30 Mar 2022
- 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
- Healthy adult volunteers aged over 19 years
- Subjects who have over 50kg and BMI more than 18.5kg/m^2 and less than 29.9kg/m^2
- Subjects who are eligible for this study as determined by clinical laboratory test results, urine test results, vital sign measurements, 12-lead ECG results, and physical examination findings during screening.
- Subjects must agree to practice a medically acceptable method of birth control and should not donate sperm or eggs until 28 days after last dose of study drug.
- Subjects who provided written informed consent to participate in this study and voluntarily taken part in during the entire study period
Who cannot join
- • Subject with any clinically significant cardiovascular, respiratory, endocrinology, infectious disease, ophthalmology, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
- History of gastrointestinal disease (except for appendectomy or herniotomy) or surgery (ex. Crohn's disease, ulcer) that may affect the absorption of a given drug
- Medical history or evidence that can affect absorption, distribution, metabolism and excretion of a given drug
- Subject with symptoms of acute disease within 28days prior to study medication dosing
- Drugs or other drugs (aspirin, antibiotics, etc.) that contain the following drug categories or components of the same strain have an overactive or clinically significant history of hypersensitivity:
- Subject with a history of drug abuse or urinalysis positive
Show all 17Show fewer
- Subject with clinically significant active chronic disease
- Subject with genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
- Genetic myopathic disorder or related family history
- Positive test results for HBs Ab, HCV Ab, Anti HIV(AIDS), RPR Ab
- Subject with clinically significant allergic disease (except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug)
- Subject who cannot take standard meal in hospitalization
- Present history of hypothyroidism or clinically significant assay
- Subjects who donated whole blood or partial blood within 2 or 1 month, respectively, prior to the first administration.
- Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 30days prior to study medication dosing
- Smokers whose average daily smoking amount exceeds 10 cigarettes per day within 3 months before the first dosing day and those who can't quit from 48 hours before dosing to the time of the last blood sampling.
- Subjects who judged ineligible by the investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
H plus yangji hospital
Seoul
MinJung Kim
About this study
Official title: An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Cross-over, Clinical Trial to Evaluate the Pharmacokinetics and the Safety of ID14009 Compared to Coadministration of ID1805 With ID1803 in Healthy Adult Volunteers.
To evaluate the pharmacokinetics and the safety of ID14009 compared to coadministration of ID1805 with ID1803 in healthy adult volunteers.
- Conditions
- Dyslipidemias, Hypertension
- Being tested
- ID140009, ID1803+ID1805
- Medical subject headings
- Dyslipidemias, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ID140009Combination product
Combination Product: ID140009 Ezetibmibe 10mg/ Rosuvastatin Ca 20.8mg/ Amlodipine 10mg/ Valsartan 160mg
ID1803+ID1805Combination product
(Amlodipine 10mg/Valsartan 160mg)+(Ezetibmibe 10mg/ Rosuvastatin Ca 20.8mg)
| Study group | Role | What they receive |
|---|---|---|
| ID140009 | Experimental | Not described Receives: Combination Product: ID140009 |
| ID1803+ID1805 | Active comparator | Not described Receives: Combination Product: ID1803+ID1805 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt (Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine)
Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine: AUCt
Measured: 0~72hr
Cmax (Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine)
Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine: Cmax
Measured: 0~72hr
Secondary outcomes (2)
AUCt (Free Ezetimibe)
Free Ezetimibe: AUCt
Measured: 0~72hr
Cmax (Free Ezetimibe)
Free Ezetimib: Cmax
Measured: 0~72hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start22 Feb 2022 (estimated)
- Primary completion30 Mar 2022 (estimated)
- Study completion30 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IlDong Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259020
- Sponsor's protocol ID
- ID-VARE-104
- Status last verified
- Feb 2022
- First submitted
- 17 Feb 2022
- Last updated
- 28 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Cross-over, Clinical Trial to Evaluate the Pharmacokinetics and the Safety of ID14009 Compared to Coadministration of ID1805 With ID1803 in Healthy Adult Volunteers.
- ClinicalTrials.gov ID
- NCT05259020
- Acronym / sponsor ID
- ID-VARE-104
- Conditions
- Dyslipidemias, Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2022 (estimated)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 28 Feb 2022 (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.
To evaluate the pharmacokinetics and the safety of ID14009 compared to coadministration of ID1805 with ID1803 in healthy adult volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ID140009 | Experimental | Combination Product: ID140009 |
| ID1803+ID1805 | Active comparator | Combination Product: ID1803+ID1805 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy adult volunteers aged over 19 years
- Subjects who have over 50kg and BMI more than 18.5kg/m^2 and less than 29.9kg/m^2
- Subjects who are eligible for this study as determined by clinical laboratory test results, urine test results, vital sign measurements, 12-lead ECG results, and physical examination findings during screening.
- Subjects must agree to practice a medically acceptable method of birth control and should not donate sperm or eggs until 28 days after last dose of study drug.
- Subjects who provided written informed consent to participate in this study and voluntarily taken part in during the entire study period
Key exclusion criteria (17 listed)
- • Subject with any clinically significant cardiovascular, respiratory, endocrinology, infectious disease, ophthalmology, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
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 |
|---|---|---|
| ID140009Combination Product: ID140009 Ezetibmibe 10mg/ Rosuvastatin Ca 20.8mg/ Amlodipine 10mg/ Valsartan 160mg | Combination product | ID140009 |
| ID1803+ID1805(Amlodipine 10mg/Valsartan 160mg)+(Ezetibmibe 10mg/ Rosuvastatin Ca 20.8mg) | Combination product | ID1803+ID1805 |
Primary outcome
AUCt (Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine)
Time frame: 0~72hr
Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine: AUCt
Cmax (Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine)
Time frame: 0~72hr
Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine: Cmax
2 secondary outcomes
AUCt (Free Ezetimibe)
Time frame: 0~72hr
Cmax (Free Ezetimibe)
Time frame: 0~72hr
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
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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.
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 ID140009 and ID1803+ID1805 in people with Dyslipidemias and Hypertension, run by IlDong Pharmaceutical Co Ltd 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 17 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 28 Feb 2022. 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 MinJung Kim (025263179, mjkim90@ildong.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCt (Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine) (time frame: 0~72hr). 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 28 Feb 2022.