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

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

Study Overview

• Status: Unknown
• Conditions: Hypertension; Dyslipidemias
• Intervention / Treatment: Combination product: ID1801; Combination product: ID1803; Combination product: ID1803+ID1801

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: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCτ(N-desmethyl rosuvastatin, total ezetimibe) desmethyl rosuvastatin, total ezetimibe: AUCτ, Cmax,ss	N-desmethyl rosuvastatin, total ezetimibe: AUCτ	0~72hours
Cmax,ss(N-desmethyl rosuvastatin, total ezetimibe) desmethyl rosuvastatin, total ezetimibe: AUCτ, Cmax,ss	N-desmethyl rosuvastatin, total ezetimibe: Cmax,ss	0~72hours
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	0~72hours
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	0~72hours
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	0~72hours
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	0~72hours
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	0~72hours
PTF(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)	amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: PTF	0~72hours

Collaborators and Investigators

• Sponsor: IlDong Pharmaceutical Co Ltd

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2020
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: November 28, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): December 26, 2019
• Last Update Submitted That Met QC Criteria: December 22, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID 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