HypertensionPhase 1NCT04185090
To Evaluate the Pharmacokinetic/Pharmacodynamic Interactions and Safety Between ID1801 and ID1803 in Healthy Male Adults
A Phase 1 study testing ID1803, ID1801 and ID1803+ID1801 in people with Hypertension and Dyslipidemias, run by IlDong Pharmaceutical Co Ltd.
Trial summary
This study is designated to evaluate the pharmacokinetic interactions of valsartan, amlodipine besylate, rosuvastatin, and ezetimibe in healthy male volunteers. 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?
- ID1803, ID1801 and ID1803+ID1801
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2020to Apr 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male volunteers aged 19 to 45 years
- Subjects who have over 50kg and BMI more than 18.5kg/m2 and less than 29.9kg/m2
- Males must be agree to practice a medically acceptable method* of birth control and will not donate sperm during the study.
- 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 serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
- Subject with symptoms of acute disease within 28days prior to study medication dosing
- Medical history or evidence that can affect absorption, distribution, metabolism and excretion of a given drug
- 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
- Subject with clinically significant active chronic disease
Show all 16Show fewer
- 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
About this study
Official title: An Open-label, Single or Multiple-dose, Fixed-sequence, 3-treatment, 3-Period Phase 1 Study to Evaluate the Pharmacokinetic/Pharmacodynamic Interactions and Safety Between ID1801 and ID1803 in Healthy Male Subjects
This study is designated to evaluate the pharmacokinetic interactions of valsartan, amlodipine besylate, rosuvastatin, and ezetimibe in healthy male volunteers.
Read the detailed description
An Open-label, Single or Multiple-dose, Fixed-sequence, 3-treatment, 3-Period phase 1 study to Evaluate the Pharmacokinetic/Pharmacodynamic Interactions and Safety between ID1801 and ID1803 in Healthy Male Subjects
- Conditions
- Hypertension, Dyslipidemias
- Being tested
- ID1803, ID1801, ID1803+ID1801
- Medical subject headings
- Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ID1803Combination product
Amlodipine 10mg/Valsartan 160mg
ID1801Combination product
Ezetimibe 10mg/Rosuvastatin Ca 20.8mg
ID1803+ID1801Combination product
Amlodipine 10mg/Valsartan 160mg Ezetimibe 10mg/Rosuvastatin Ca 20.8mg
| Study group | Role | What they receive |
|---|---|---|
| ID1801 | Active comparator | qd daily for 6days Intervention: Drug: administration of ID1801 for 6days. Receives: Combination Product: ID1801 |
| ID1803 | Active comparator | qd daily for 10days Intervention: Drug: administration of ID1803 for 10days. Receives: Combination Product: ID1803 |
| ID1801 and ID1803 | Experimental | qd daily for 7days Intervention: Drug: administration of ID1801 and ID1803. Receives: Combination Product: ID1803+ID1801 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCτ(Amlodipine, valsartan, rosuvastatin, free ezetimibe)
Amlodipine, valsartan, rosuvastatin, free ezetimibe: AUCτ
Measured: 0~72hours
Cmax,ss(Amlodipine, valsartan, rosuvastatin, free ezetimibe)
Amlodipine, valsartan, rosuvastatin, free ezetimibe: Cmax,ss
Measured: 0~72hours
Secondary outcomes (8)
AUCτ(N-desmethyl rosuvastatin, total ezetimibe) desmethyl rosuvastatin, total ezetimibe: AUCτ, Cmax,ss
N-desmethyl rosuvastatin, total ezetimibe: AUCτ
Measured: 0~72hours
Cmax,ss(N-desmethyl rosuvastatin, total ezetimibe) desmethyl rosuvastatin, total ezetimibe: AUCτ, Cmax,ss
N-desmethyl rosuvastatin, total ezetimibe: Cmax,ss
Measured: 0~72hours
Cmin,ss(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)
amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: Cmin,ss
Measured: 0~72hours
Tmax,ss(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)
amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: Tmax,ss
Measured: 0~72hours
t1/2(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)
amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: t1/2
Measured: 0~72hours
CLss/F(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)
amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: CLss/F
Measured: 0~72hours
Vd/F(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)
amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: Vd/F
Measured: 0~72hours
PTF(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)
amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: PTF
Measured: 0~72hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study startFeb 2020 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (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.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT04185090
- Sponsor's protocol ID
- ID-VARE-101
- Status last verified
- Nov 2019
- First submitted
- 28 Nov 2019
- Last updated
- 26 Dec 2019
- 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 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single or Multiple-dose, Fixed-sequence, 3-treatment, 3-Period Phase 1 Study to Evaluate the Pharmacokinetic/Pharmacodynamic Interactions and Safety Between ID1801 and ID1803 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04185090
- Acronym / sponsor ID
- ID-VARE-101
- Conditions
- Hypertension, Dyslipidemias
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- Feb 2020 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 4 Dec 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.
This study is designated to evaluate the pharmacokinetic interactions of valsartan, amlodipine besylate, rosuvastatin, and ezetimibe in healthy male volunteers.
Detailed description
An Open-label, Single or Multiple-dose, Fixed-sequence, 3-treatment, 3-Period phase 1 study to Evaluate the Pharmacokinetic/Pharmacodynamic Interactions and Safety between ID1801 and ID1803 in Healthy Male Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ID1801 | Active comparator | Combination Product: ID1801qd daily for 6days Intervention: Drug: administration of ID1801 for 6days. |
| ID1803 | Active comparator | Combination Product: ID1803qd daily for 10days Intervention: Drug: administration of ID1803 for 10days. |
| ID1801 and ID1803 | Experimental | Combination Product: ID1803+ID1801qd daily for 7days Intervention: Drug: administration of ID1801 and ID1803. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult male volunteers aged 19 to 45 years
- Subjects who have over 50kg and BMI more than 18.5kg/m2 and less than 29.9kg/m2
- Males must be agree to practice a medically acceptable method* of birth control and will not donate sperm during the study.
- Subjects who provided written informed consent to participate in this study and voluntarily taken part in during the entire study period
Key exclusion criteria (16 listed)
- Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
- Subject with symptoms of acute disease within 28days prior to study medication dosing
- Medical history or evidence that can affect absorption, distribution, metabolism and excretion of a given drug
- 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
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 |
|---|---|---|
| ID1803Amlodipine 10mg/Valsartan 160mg | Combination product | ID1803 |
| ID1801Ezetimibe 10mg/Rosuvastatin Ca 20.8mg | Combination product | ID1801 |
| ID1803+ID1801Amlodipine 10mg/Valsartan 160mg Ezetimibe 10mg/Rosuvastatin Ca 20.8mg | Combination product | ID1801 and ID1803 |
Primary outcome
AUCτ(Amlodipine, valsartan, rosuvastatin, free ezetimibe)
Time frame: 0~72hours
Amlodipine, valsartan, rosuvastatin, free ezetimibe: AUCτ
Cmax,ss(Amlodipine, valsartan, rosuvastatin, free ezetimibe)
Time frame: 0~72hours
Amlodipine, valsartan, rosuvastatin, free ezetimibe: Cmax,ss
8 secondary outcomes
AUCτ(N-desmethyl rosuvastatin, total ezetimibe) desmethyl rosuvastatin, total ezetimibe: AUCτ, Cmax,ss
Time frame: 0~72hours
Cmax,ss(N-desmethyl rosuvastatin, total ezetimibe) desmethyl rosuvastatin, total ezetimibe: AUCτ, Cmax,ss
Time frame: 0~72hours
Cmin,ss(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)
Time frame: 0~72hours
Tmax,ss(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)
Time frame: 0~72hours
t1/2(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)
Time frame: 0~72hours
CLss/F(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)
Time frame: 0~72hours
Vd/F(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)
Time frame: 0~72hours
PTF(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)
Time frame: 0~72hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ID1803, ID1801 and ID1803+ID1801 in people with Hypertension and Dyslipidemias, run by IlDong Pharmaceutical Co Ltd.
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 4 inclusion and 16 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 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
AUCτ(Amlodipine, valsartan, rosuvastatin, free ezetimibe) (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?
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 26 Dec 2019.