A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Ezerosu Tab

January 24, 2024 updated by: Shin Poong Pharmaceutical Co. Ltd.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Evaluate the Safety

  1. Adverse Events
  2. Concomitant Medications
  3. Vital Signs
  4. Laboratory Test

Pharmacokinetics

  1. 1st Evaluation Variable: 1st Cmax, AUCt of Total Ezetimibe, Rosuvastatin
  2. 2nd Evaluation Variable: AUC∞, Tmax, t1/2 of Total Ezetimibe, Rosuvastatin and Cmax, AUCt, AUC∞, Tmax, t1/2 of Free Ezetimibe

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Those who are 19 years old or older at the time of the screening visit

  2. 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

  3. 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.
  4. 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

  5. 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

  6. 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.

Exclusion Criteria:

  1. 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
  2. Those who have past ability of gastrointestinal surgery (excluding simple appendectomy and hernia surgery) that can affect drug absorption, or have gastrointestinal illness
  3. 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)
  4. Those who participated in other clinical trials or bioequivalence studies and received clinical trial drugs within 6 months of the first dosing date.
  5. Those who donated whole blood or component blood within 2 weeks or received blood transfusion within 4 weeks on the first dosing day

  6. Those who meet the following conditions within one month of the first dosing date

    • 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

  7. 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

  8. 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
  9. 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.
  10. In the case of female applicants, pregnant women or those who are suspected of becoming pregnant or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Test
Ezerosu tablet(double layer tablet)
Drug: Ezerosu(monolayer tablet)
Ezetimibe 10mg, Rosuvastatin calcium 20.8mg(20mg as Rosuvastatin)
Drug: Ezerosu(double layer tablet)
Ezetimibe 10mg, Rosuvastatin calcium 20.8mg(20mg as Rosuvastatin)
Active Comparator: Control
Ezerosu tablet(monolayer tablet)
Drug: Ezerosu(monolayer tablet)
Ezetimibe 10mg, Rosuvastatin calcium 20.8mg(20mg as Rosuvastatin)
Drug: Ezerosu(double layer tablet)
Ezetimibe 10mg, Rosuvastatin calcium 20.8mg(20mg as Rosuvastatin)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cmax of Total Ezetimibe, Rosuvastatin
Time Frame: follow up to Day8
Cmax of Total Ezetimibe, Rosuvastatin
follow up to Day8
AUCt of Total Ezetimibe, Rosuvastatin
Time Frame: follow up to Day8
AUCt of Total Ezetimibe, Rosuvastatin
follow up to Day8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
AUC∞ of Total Ezetimibe, Rosuvastatin and AUC∞ of Free Ezetimibe
Time Frame: follow up to Day8
AUC∞ of Total Ezetimibe, Rosuvastatin and AUC∞ of Free Ezetimibe
follow up to Day8
Tmax of Total Ezetimibe, Rosuvastatin and Tmax of Free Ezetimibe
Time Frame: follow up to Day8
Tmax of Total Ezetimibe, Rosuvastatin and Tmax of Free Ezetimibe
follow up to Day8
t1/2 of Total Ezetimibe, Rosuvastatin and t1/2 of Free Ezetimibe
Time Frame: follow up to Day8
t1/2 of Total Ezetimibe, Rosuvastatin and t1/2 of Free Ezetimibe
follow up to Day8
Cmax of Free Ezetimibe
Time Frame: follow up to Day8
Cmax of Free Ezetimibe
follow up to Day8
AUCt of Free Ezetimibe
Time Frame: follow up to Day8
AUCt of Free Ezetimibe
follow up to Day8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shin Poong Pharmaceutical Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 7, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 7, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SP-RE-HYP-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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