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Keep this study
Lead
IlDong Pharmaceutical Co Ltd
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
Age
19–45
Sex
MALE
Healthy volunteers
Accepted
You may be eligible 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 be 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.
Subjects who judged ineligible by the investigator
Clareo Health | To Evaluate the Pharmacokinetic/Pharmacodynamic Interactions and Safety Between ID1801 and ID1803 in Healthy Male Adults
