To Evaluate the Pharmacokinetic/Pharmacodynamic Interactions and Safety Between ID1801 and ID1803 in Healthy Male Adults

December 22, 2019 updated by: IlDong Pharmaceutical Co Ltd

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.

Study Overview

Status

Status

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

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

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 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 (Anticipated)

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.
30

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

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

19 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

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: Non-Randomized
  • Interventional Model: Sequential 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.
Active Comparator: ID1801
qd daily for 6days Intervention: Drug: administration of ID1801 for 6days.
Combination product: ID1801
Ezetimibe 10mg/Rosuvastatin Ca 20.8mg
Active Comparator: ID1803
qd daily for 10days Intervention: Drug: administration of ID1803 for 10days.
Combination product: ID1803
Amlodipine 10mg/Valsartan 160mg
Experimental: ID1801 and ID1803
qd daily for 7days Intervention: Drug: administration of ID1801 and ID1803.
Combination product: ID1803+ID1801
Amlodipine 10mg/Valsartan 160mg Ezetimibe 10mg/Rosuvastatin Ca 20.8mg

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
AUCτ(Amlodipine, valsartan, rosuvastatin, free ezetimibe)
Time Frame: 0~72hours
Amlodipine, valsartan, rosuvastatin, free ezetimibe: AUCτ
0~72hours
Cmax,ss(Amlodipine, valsartan, rosuvastatin, free ezetimibe)
Time Frame: 0~72hours
Amlodipine, valsartan, rosuvastatin, free ezetimibe: Cmax,ss
0~72hours

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
AUCτ(N-desmethyl rosuvastatin, total ezetimibe) desmethyl rosuvastatin, total ezetimibe: AUCτ, Cmax,ss
Time Frame: 0~72hours
N-desmethyl rosuvastatin, total ezetimibe: AUCτ
0~72hours
Cmax,ss(N-desmethyl rosuvastatin, total ezetimibe) desmethyl rosuvastatin, total ezetimibe: AUCτ, Cmax,ss
Time Frame: 0~72hours
N-desmethyl rosuvastatin, total ezetimibe: Cmax,ss
0~72hours
Cmin,ss(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)
Time Frame: 0~72hours
amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: Cmin,ss
0~72hours
Tmax,ss(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)
Time Frame: 0~72hours
amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: Tmax,ss
0~72hours
t1/2(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)
Time Frame: 0~72hours
amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: t1/2
0~72hours
CLss/F(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)
Time Frame: 0~72hours
amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: CLss/F
0~72hours
Vd/F(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)
Time Frame: 0~72hours
amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: Vd/F
0~72hours
PTF(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)
Time Frame: 0~72hours
amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: PTF
0~72hours

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.
IlDong 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 (Anticipated)

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.
February 1, 2020

Primary Completion (Anticipated)

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.
April 1, 2020

Study Completion (Anticipated)

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.
April 1, 2020

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).
November 28, 2019

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.
December 3, 2019

First Posted (Actual)

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.
December 4, 2019

Study Record Updates

Last Update Posted (Actual)

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.
December 26, 2019

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.
December 22, 2019

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.
November 1, 2019

More Information

Terms related to this study

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.
  • ID-VARE-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

product manufactured in and exported from the U.S.

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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