Status and phase
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Volunteers
Inclusion criteria
Male volunteers in the age between 20 and 45 years old
Subject with no history of any significant chronic disease
Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data for this trial by investigators
Willing to adhere to protocol requirements and sign a informed consent form
Exclusion criteria
History of clinically significant allergies, including Bepotastine.
History of clinically significant hepatic, renal, neurology, psychiatric, pulmonary, endocrine, hematologic, cardiovascular disease
History of surgery except or gastrointestinal disease which might significantly change absorption of medicines
Subjects considered as unsuitable health on the basis of their vital sign, ECG, physical exam and routine laboratory data for this trial by investigators.
Clinical laboratory test values are outside the accepted normal range
Estimated GFR(Glomerular Filtration Rate) < 80 mL/min/1.73m2
Clinically significant vital sign
History of drug abuse or positive urine screen for drugs
History of caffeine, alcohol, smoking abuse
Special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration
Use of prescription only medicine and oriental medicine within the 14 days before dosing or use of non-prescription medicine within the 7 days before dosing
Participated in a previous clinical trial within 60 days prior to dosing
Donated blood within 60 days prior to dosing
Subjects considered as unsuitable based on medical judgement by investigators
Primary purpose
Allocation
Interventional model
Masking
30 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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