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

NCT ID: NCT04185090

Last Updated: 2019-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-29

Study Completion Date

2020-04-30

Brief Summary

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This study is designated to evaluate the pharmacokinetic interactions of valsartan, amlodipine besylate, rosuvastatin, and ezetimibe in healthy male volunteers.

Detailed Description

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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

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Hypertension Dyslipidemias

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ID1801

qd daily for 6days Intervention: Drug: administration of ID1801 for 6days.

Group Type ACTIVE_COMPARATOR

ID1801

Intervention Type COMBINATION_PRODUCT

Ezetimibe 10mg/Rosuvastatin Ca 20.8mg

ID1803

qd daily for 10days Intervention: Drug: administration of ID1803 for 10days.

Group Type ACTIVE_COMPARATOR

ID1803

Intervention Type COMBINATION_PRODUCT

Amlodipine 10mg/Valsartan 160mg

ID1801 and ID1803

qd daily for 7days Intervention: Drug: administration of ID1801 and ID1803.

Group Type EXPERIMENTAL

ID1803+ID1801

Intervention Type COMBINATION_PRODUCT

Amlodipine 10mg/Valsartan 160mg Ezetimibe 10mg/Rosuvastatin Ca 20.8mg

Interventions

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ID1803

Amlodipine 10mg/Valsartan 160mg

Intervention Type COMBINATION_PRODUCT

ID1801

Ezetimibe 10mg/Rosuvastatin Ca 20.8mg

Intervention Type COMBINATION_PRODUCT

ID1803+ID1801

Amlodipine 10mg/Valsartan 160mg Ezetimibe 10mg/Rosuvastatin Ca 20.8mg

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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IlDong Pharmaceutical Co Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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ID-VARE-101

Identifier Type: -

Identifier Source: org_study_id