HyperlipidemiasPhase 1NCT06225635
A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Ezerosu Tab
A Phase 1 study testing Ezerosu(monolayer tablet) and Ezerosu(double layer tablet) in people with Hyperlipidemias, run by Shin Poong Pharmaceutical Co. Ltd. at 1 site in South Korea.
Trial summary
A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Ezerosu Tab Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemias
- What is being tested?
- Ezerosu(monolayer tablet) and Ezerosu(double layer tablet)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2022to 7 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
- Those who are 19 years old or older at the time of the screening visit
- At the time of screening visit, those who weigh 50 kg or more for men, 45 kg or more for women, and have a body mass index (BMI) of 18.0 kg / m2 or more and 30.0 kg / m2 or less.
- ☞ BMI (kg / m2) = Weight (kg) / {Height (m)} 2
- Those who have no clinically significant congenital or chronic illness at the time of the screening visit and have no medical examination results, pathological symptoms or findings.
- Diagnostic tests such as hematology tests, blood chemistry tests, serum tests, urine tests, and electrocardiogram test result tests set and performed by the test director (or the commissioned doctor in charge of the test) according to the characteristics of the clinical test drug. Now that it has been determined to fit the subject
- Clinical trial drug From the first dosing date to the last clinical trial drug 14 days from the dosing date, the person, sperm, or partner should use medically appropriate contraceptive methods * to eliminate the possibility of pregnancy. Agree and agree not to donate sperm or eggs
- Contraceptives: Combined use or killing of intrauterine devices, sperm surgery, tubal contraception and blockage contraceptives (male condoms, female condoms, cervical caps, contraceptive diaphragms, sponges, etc.) When using spermicide, use two or more contraceptive methods as a combination
- A person who has signed a consent form by a free doctor after listening to and understanding the purpose and content of this clinical trial, the characteristics of the drug for clinical trial, expected abnormal reactions, etc.
Who cannot join
- Digestive system, cardiovascular system, endocrine system, respiratory system, blood / tumor, infectious disease, kidney and urogenital system, psychiatric / nervous system, musculoskeletal system, immune system, otolaryngology, dermatology, ophthalmology People with clinically significant illness or past strength who fall into the system
- Those who have past ability of gastrointestinal surgery (excluding simple appendectomy and hernia surgery) that can affect drug absorption, or have gastrointestinal illness
- Those who took drug-metabolizing enzyme-inducing and inhibitory drugs such as barbital drugs within 1 month of the first dosing date, or took drugs that may interfere with this clinical study within 10 days of the first dosing date (however) , Interaction with clinical study drugs, half-life of concomitant drugs, etc. Can be participated in consideration of drug dynamics and pharmacodynamics)
- Those who participated in other clinical trials or bioequivalence studies and received clinical trial drugs within 6 months of the first dosing date.
- Those who donated whole blood or component blood within 2 weeks or received blood transfusion within 4 weeks on the first dosing day
- Those who meet the following conditions within one month of the first dosing date
Show all 26Show fewer
- For men, alcohol intake exceeding 21 cups / week on average
- For females, alcohol intake exceeding 14 cups / week on average
- (1 cup = 50 mL of shochu or 30 mL of Western liquor or 250 mL of beer)
- Smoking an average of 20 cigarettes or more per day
- Those who fall under the following
- ・ Persons with hypersensitivity to the main ingredients or constituents of this drug
- Persons with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Patients with the following diseases
- Patients with active liver disease or patients with persistently high symptoms due to unknown causes of serum amino transduction enzyme levels
- Patients with muscle disease
- Patients receiving cyclosporine in combination
- Patients with moderate renal disorder or severe renal failure (eGFR <60 ml / min / 1.73 m2)
- Patients who are susceptible to myopathy and rhabdomyolysis
- Patients with hypothyroidism
- Patients with a history of genetic muscle disease or family history
- -Patients with a history of muscle toxicity to statins (HMG-CoA convertase inhibitors) or fibrates
- Alcoholics
- Patients treated with fibrates
- Persons who are judged by the investigator (or the commissioned investigator) to be unsuitable for participation in this clinical study due to reasons other than the above selection / exclusion criteria.
- In the case of female applicants, pregnant women or those who are suspected of becoming pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Ezerosu Tab. 10/20 mg(Single-layer Tablet) Compared to Ezerosu Tab. 10/20 mg(Double-layer Tablet) in Healthy Adult Volunteers
A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Ezerosu Tab
Read the detailed description
Evaluate the Safety
- Adverse Events
- Concomitant Medications
- Vital Signs
- Laboratory Test
Pharmacokinetics
- 1st Evaluation Variable: 1st Cmax, AUCt of Total Ezetimibe, Rosuvastatin
- 2nd Evaluation Variable: AUC∞, Tmax, t1/2 of Total Ezetimibe, Rosuvastatin and Cmax, AUCt, AUC∞, Tmax, t1/2 of Free Ezetimibe
- Conditions
- Hyperlipidemias
- Being tested
- Ezerosu(monolayer tablet), Ezerosu(double layer tablet)
- Keywords
- Arteriosclerosis, Primary Hypercholesterolemia, Hyperlipidemias
- Medical subject headings
- Hyperlipidemias, Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ezerosu(monolayer tablet)Drug
Ezetimibe 10mg, Rosuvastatin calcium 20.8mg(20mg as Rosuvastatin)
Ezerosu(double layer tablet)Drug
Ezetimibe 10mg, Rosuvastatin calcium 20.8mg(20mg as Rosuvastatin)
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Ezerosu tablet(double layer tablet) Receives: Drug: Ezerosu(monolayer tablet); Drug: Ezerosu(double layer tablet) |
| Control | Active comparator | Ezerosu tablet(monolayer tablet) Receives: Drug: Ezerosu(monolayer tablet); Drug: Ezerosu(double layer tablet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Total Ezetimibe, Rosuvastatin
Cmax of Total Ezetimibe, Rosuvastatin
Measured: follow up to Day8
AUCt of Total Ezetimibe, Rosuvastatin
AUCt of Total Ezetimibe, Rosuvastatin
Measured: follow up to Day8
Secondary outcomes (5)
AUC∞ of Total Ezetimibe, Rosuvastatin and AUC∞ of Free Ezetimibe
AUC∞ of Total Ezetimibe, Rosuvastatin and AUC∞ of Free Ezetimibe
Measured: follow up to Day8
Tmax of Total Ezetimibe, Rosuvastatin and Tmax of Free Ezetimibe
Tmax of Total Ezetimibe, Rosuvastatin and Tmax of Free Ezetimibe
Measured: follow up to Day8
t1/2 of Total Ezetimibe, Rosuvastatin and t1/2 of Free Ezetimibe
t1/2 of Total Ezetimibe, Rosuvastatin and t1/2 of Free Ezetimibe
Measured: follow up to Day8
Cmax of Free Ezetimibe
Cmax of Free Ezetimibe
Measured: follow up to Day8
AUCt of Free Ezetimibe
AUCt of Free Ezetimibe
Measured: follow up to Day8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start1 Jan 2022
- Primary completion7 Mar 2022
- Study completion7 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiasStudies 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 (actual)
Sponsor and investigators
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225635
- Sponsor's protocol ID
- SP-RE-HYP-101
- Status last verified
- Mar 2022
- First submitted
- 13 Dec 2021
- Last updated
- 26 Jan 2024
- 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 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Ezerosu Tab. 10/20 mg(Single-layer Tablet) Compared to Ezerosu Tab. 10/20 mg(Double-layer Tablet) in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT06225635
- Acronym / sponsor ID
- SP-RE-HYP-101
- Conditions
- Hyperlipidemias
- Keywords
- Arteriosclerosis, Primary Hypercholesterolemia, Hyperlipidemias
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 7 Mar 2022 (actual)
- Study completion
- 7 Mar 2022 (actual)
- First posted
- 26 Jan 2024 (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 Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Ezerosu Tab
Detailed description
Evaluate the Safety
- Adverse Events
- Concomitant Medications
- Vital Signs
- Laboratory Test
Pharmacokinetics
- 1st Evaluation Variable: 1st Cmax, AUCt of Total Ezetimibe, Rosuvastatin
- 2nd Evaluation Variable: AUC∞, Tmax, t1/2 of Total Ezetimibe, Rosuvastatin and Cmax, AUCt, AUC∞, Tmax, t1/2 of Free Ezetimibe
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Drug: Ezerosu(monolayer tablet), Drug: Ezerosu(double layer tablet)Ezerosu tablet(double layer tablet) |
| Control | Active comparator | Drug: Ezerosu(monolayer tablet), Drug: Ezerosu(double layer tablet)Ezerosu tablet(monolayer tablet) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Those who are 19 years old or older at the time of the screening visit
- At the time of screening visit, those who weigh 50 kg or more for men, 45 kg or more for women, and have a body mass index (BMI) of 18.0 kg / m2 or more and 30.0 kg / m2 or less.
- ☞ BMI (kg / m2) = Weight (kg) / {Height (m)} 2
- Those who have no clinically significant congenital or chronic illness at the time of the screening visit and have no medical examination results, pathological symptoms or findings.
- Diagnostic tests such as hematology tests, blood chemistry tests, serum tests, urine tests, and electrocardiogram test result tests set and performed by the test director (or the commissioned doctor in charge of the test) according to the characteristics of the clinical test drug. Now that it has been determined to fit the subject
Key exclusion criteria (26 listed)
- Digestive system, cardiovascular system, endocrine system, respiratory system, blood / tumor, infectious disease, kidney and urogenital system, psychiatric / nervous system, musculoskeletal system, immune system, otolaryngology, dermatology, ophthalmology People with clinically significant illness or past strength who fall into the system
- Those who have past ability of gastrointestinal surgery (excluding simple appendectomy and hernia surgery) that can affect drug absorption, or have gastrointestinal illness
- Those who took drug-metabolizing enzyme-inducing and inhibitory drugs such as barbital drugs within 1 month of the first dosing date, or took drugs that may interfere with this clinical study within 10 days of the first dosing date (however) , Interaction with clinical study drugs, half-life of concomitant drugs, etc. Can be participated in consideration of drug dynamics and pharmacodynamics)
- Those who participated in other clinical trials or bioequivalence studies and received clinical trial drugs within 6 months of the first dosing date.
- Those who donated whole blood or component blood within 2 weeks or received blood transfusion within 4 weeks on the first dosing day
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 |
|---|---|---|
| Ezerosu(monolayer tablet)Ezetimibe 10mg, Rosuvastatin calcium 20.8mg(20mg as Rosuvastatin) | Drug | Control, Test |
| Ezerosu(double layer tablet)Ezetimibe 10mg, Rosuvastatin calcium 20.8mg(20mg as Rosuvastatin) | Drug | Control, Test |
Primary outcome
Cmax of Total Ezetimibe, Rosuvastatin
Time frame: follow up to Day8
Cmax of Total Ezetimibe, Rosuvastatin
AUCt of Total Ezetimibe, Rosuvastatin
Time frame: follow up to Day8
AUCt of Total Ezetimibe, Rosuvastatin
5 secondary outcomes
AUC∞ of Total Ezetimibe, Rosuvastatin and AUC∞ of Free Ezetimibe
Time frame: follow up to Day8
Tmax of Total Ezetimibe, Rosuvastatin and Tmax of Free Ezetimibe
Time frame: follow up to Day8
t1/2 of Total Ezetimibe, Rosuvastatin and t1/2 of Free Ezetimibe
Time frame: follow up to Day8
Cmax of Free Ezetimibe
Time frame: follow up to Day8
AUCt of Free Ezetimibe
Time frame: follow up to Day8
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 26 Jan 2024.
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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.
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 Ezerosu(monolayer tablet) and Ezerosu(double layer tablet) in people with Hyperlipidemias, run by Shin Poong 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 8 inclusion and 26 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 26 Jan 2024. 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?
Cmax of Total Ezetimibe, Rosuvastatin (time frame: follow up to Day8). 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 Jan 2024.