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

IlDong Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Hypertension; Dyslipidemias

Treatments: Combination Product: ID1803; Combination Product: ID1801; Combination Product: ID1803+ID1801

Study type: Interventional

Funder types: Industry

Identifiers

NCT04185090

ID-VARE-101

Details and patient eligibility

About

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

Full 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

Enrollment: 30 estimated patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

ID1801

Active Comparator group

Description:

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

Treatment:

Combination Product: ID1801

ID1803

Active Comparator group

Description:

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

Treatment:

Combination Product: ID1803

ID1801 and ID1803

Experimental group

Description:

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

Treatment:

Combination Product: ID1803+ID1801