KCT0004393已完成未知
A randomized, open-label, single-dose, crossover clinical study to compare the effect of food on the pharmacokinetic characteristics and the safety after oral administration of SR formulation of bepotastine in healthy adult subjects
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) Healthy adult volunteers aged 19years old at screening
- •2) Body weight more than 50kg and Body Mass Index(BMI) 18.0kg/m2 ~ 30.0 kg/m2
- •? BMI(kg/m2) = Body weight (kg) / {height (m)}2
- •3) Subject should not have congenital/chronic disease or pathological symptoms/findings
- •4) Subject judged to be eligible by clinical laboratory tests such as serum test, hematology test, blood chemistry test, blood coagulation test, urine test, urine drug test, and 12-lead electrocardiogram test were performed according to the characteristics of the drug during the screening test.
- •5) Subject who is not pregnant.
- •6) Subject who fully understands the clinical trials after in-depth explanation, volunteers to join the clinical trials and signs inform consent
排除标准
- •1) Person with clinically significant liver dysfunction, kidney, respiratory system, blood / tumor system, endocrine system, urinary system, cardiovascular system, nervous system, musculoskeletal system, psychiatric disorder
- •? Patients with renal impairment
- •? Patients with dyshepatia
- •2) Those who have a history of hypersensitivity reaction to clinically significant components or constituents of clinical trial medicines or other clinically significant drugs or additives
- •3) Women who are pregnant and women who are lactating.
- •4) Persons with a history of gastrointestinal disorders (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of pharmaceuticals for clinical trials
- •5) At the screening, 12-lead electrocardiogram with clinically significant findings including the following findings.
- •? QTc > 450 msec
- •? PR interval > 200 msec
- •? QRS duration > 120 msec
- •6)When screening, Thoes whose results of clinical laboratory tests show the following results.(However, if the result on the day of the test is judged to be caused by clinically meaningless trasient changes or one-time drinking habits such as one-time drinking and night shift, it can be confirmed through the post-correction follow-up examination.)
- •? Liver function tests AST, ALT, ALP, ?-GTP and Bilirubin total exceed 2 times the upper limit of normal range
- •? If serum creatinine level exceeds the normal range or eGFR calculated by the Modification of Diet in Renal Disease (MDRD) is less than 60 mL / min / 1.73 m2
- •7) A person who has a history of drug abuse or has been tested positive by a screening test
- •8) At the time of screening, after resting for more than 3 minutes, at the vital sign measured in a sitting position, the systolic blood pressure = 150 mmHg or =90 mmHg or the diastolic blood pressure =100 mmHg or =60 mmHg, pulse = 40 bpm or = 100 bpm.
- •9) Taking metabolizing enzyme inducers or inhibitors such as barbitals within one month before the first administration.
- •10) Food supplements that may affect abnormal metabolism or metabolism that may affect absorption, distribution, metabolism and excretion of drugs.
- •11) In the case of taking any special medicines (ETC drugs) or herbal medicines, within 2 weeks before the first dosing day, or taking any general medicines (OTC medicines) or vitamin preparations within 1 week, If it is determined that it may affect the test or affect the safety of the testee.
- •12) Those who have participated in other clinical trials or bioequivalence studies within 6 months of the first administration day and administered the clinical trial drug
- •13) One who whole blood donation in two months or apheresis donation in one month before administraing the first Investigational product .
- •14) Drinking continuously (21 units / week, 1 unit = 10 g = 12.5 mL of pure alcohol) within 6 months of the first administration, or one person who can not abstain (250 ml) = 10 g, shochu (20%) 1 glass (50 ml) = 8 g, wine (12%) 1 glass (125 ml) = 12 g)
- •15) 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 24 hours before dosing to the time of the last blood sampling.
- •16) Grapefruit (grapefruit) containing or consuming food containing grapefruit for 48 hours before the first administration and during PSV until the time of the clinical tri
研究者
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