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To Evaluate the Pharmacokinetic/Pharmacodynamic Interactions and Safety Between ID1801 and ID1803 in Healthy Male Adults | Clinical Trials | Clareo Health

UNKNOWNPHASE1

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

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

NCT04185090•IlDong Pharmaceutical Co Ltd

View on ClinicalTrials.gov

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

Eligibility

Age

19 - 45 years

Sex

MALE

Healthy Volunteers

Yes

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)
+6 more criteria

Key Dates

Start Date

February 1, 2020

Primary Completion Date

April 1, 2020

Completion Date

April 1, 2020

Last Updated

December 26, 2019

Enrollment

ESTIMATED participants

Conditions

HypertensionDyslipidemias

Interventions

ID1803

COMBINATION_PRODUCT

ID1801

COMBINATION_PRODUCT

ID1803+ID1801

COMBINATION_PRODUCT

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

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RECRUITINGPHASE2

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

NCT07073820

Pulmonary Hypertension

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 26, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

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