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

NCT04185090 | Unknown Phase 1

• 1 other identifier: ID-VARE-101
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hypertension; Dyslipidemias

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

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

  0~72hours

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

  0~72hours

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

  0~72hours

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

  0~72hours

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

  0~72hours

Study Arms (3)

ID1801

ACTIVE COMPARATOR

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

Combination Product: ID1801

ID1803

ACTIVE COMPARATOR

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

Combination Product: ID1803

ID1801 and ID1803

EXPERIMENTAL

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

Combination Product: ID1803+ID1801

Interventions

ID1803 COMBINATION_PRODUCT

Amlodipine 10mg/Valsartan 160mg

ID1803

ID1801 COMBINATION_PRODUCT

Ezetimibe 10mg/Rosuvastatin Ca 20.8mg

ID1801

ID1803+ID1801 COMBINATION_PRODUCT

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

ID1801 and ID1803

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IlDong Pharmaceutical Co Ltd: lead

MeSH Terms

Conditions

Hypertension; Dyslipidemias

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 4, 2019
• Study Start: February 1, 2020
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: December 26, 2019

Record last verified: 2019-11