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

Primary Purpose

Hypertension, Dyslipidemias

Status

Unknown status

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

ID1803

ID1801

ID1803+ID1801

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

19 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

ID1801

ID1803

ID1801 and ID1803

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

AUCτ(Amlodipine, valsartan, rosuvastatin, free ezetimibe)

Amlodipine, valsartan, rosuvastatin, free ezetimibe: AUCτ

Cmax,ss(Amlodipine, valsartan, rosuvastatin, free ezetimibe)

Amlodipine, valsartan, rosuvastatin, free ezetimibe: Cmax,ss

Secondary Outcome Measures

AUCτ(N-desmethyl rosuvastatin, total ezetimibe) desmethyl rosuvastatin, total ezetimibe: AUCτ, Cmax,ss

N-desmethyl rosuvastatin, total ezetimibe: AUCτ

Cmax,ss(N-desmethyl rosuvastatin, total ezetimibe) desmethyl rosuvastatin, total ezetimibe: AUCτ, Cmax,ss

N-desmethyl rosuvastatin, total ezetimibe: Cmax,ss

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

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

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

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

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

PTF(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)

amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: PTF

Full Information

NCT ID

NCT04185090

First Posted

November 28, 2019

Last Updated

December 22, 2019

Sponsor

IlDong Pharmaceutical Co Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04185090

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Unknown status

Study Start Date

February 2020 (Anticipated)

Primary Completion Date

April 2020 (Anticipated)

Study Completion Date

April 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

IlDong Pharmaceutical Co Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Dyslipidemias

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ID1801

Arm Type

Active Comparator

Arm Description

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

Arm Title

ID1803

Arm Type

Active Comparator

Arm Description

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

Arm Title

ID1801 and ID1803

Arm Type

Experimental

Arm Description

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

Intervention Type

Combination Product

Intervention Name(s)

ID1803

Intervention Description

Amlodipine 10mg/Valsartan 160mg

Intervention Type

Combination Product

Intervention Name(s)

ID1801

Intervention Description

Ezetimibe 10mg/Rosuvastatin Ca 20.8mg

Intervention Type

Combination Product

Intervention Name(s)

ID1803+ID1801

Intervention Description

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

Primary Outcome Measure Information:

Title

AUCτ(Amlodipine, valsartan, rosuvastatin, free ezetimibe)

Description

Amlodipine, valsartan, rosuvastatin, free ezetimibe: AUCτ

Time Frame

0~72hours

Title

Cmax,ss(Amlodipine, valsartan, rosuvastatin, free ezetimibe)

Description

Amlodipine, valsartan, rosuvastatin, free ezetimibe: Cmax,ss

Time Frame

0~72hours

Secondary Outcome Measure Information:

Title

AUCτ(N-desmethyl rosuvastatin, total ezetimibe) desmethyl rosuvastatin, total ezetimibe: AUCτ, Cmax,ss

Description

N-desmethyl rosuvastatin, total ezetimibe: AUCτ

Time Frame

0~72hours

Title

Cmax,ss(N-desmethyl rosuvastatin, total ezetimibe) desmethyl rosuvastatin, total ezetimibe: AUCτ, Cmax,ss

Description

N-desmethyl rosuvastatin, total ezetimibe: Cmax,ss

Time Frame

0~72hours

Title

Cmin,ss(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)

Description

amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: Cmin,ss

Time Frame

0~72hours

Title

Tmax,ss(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)

Description

amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: Tmax,ss

Time Frame

0~72hours

Title

t1/2(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)

Description

amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: t1/2

Time Frame

0~72hours

Title

CLss/F(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)

Description

amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: CLss/F

Time Frame

0~72hours

Title

Vd/F(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)

Description

amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: Vd/F

Time Frame

0~72hours

Title

PTF(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)

Description

amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: PTF

Time Frame

0~72hours

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Learn more about this trial

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

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