KCT0001123已完成未知
A Randomized, Open-label, Single-Dose, 2-Treatment, 2-Way, 2-Period Crossover Study to Compare the Safety and the Pharmacokinetic Characteristics of Mosapride/Rebamipide Combination Tablet with Mosapride and Rebamipide Tablet in Healthy Male Korean 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
- 20(Year) 至 45(Year)（—）
- 性别
- Male
入选标准
- •1)Healthy male korean subjects age 20 to 45 at the screening visit
- •2)over 55kg with ideal body weight (BMI ? 20%)
- •3)Subject who has no congenital, chronic disease and disease symptoms in medical examination result.
- •4)Subject who is judged to be eligible according to clinical laboratory tests including hematological examination, blood chemistry examination, urine analysis.
- •5)Subject who volunteerly determined to participate in and agreed to comply with precautions after totally understand the detailed explanations about this study.
排除标准
- •1)Subject who has history or presence of clinically significant disease in liver, kidney, nervous system, respiratory system, blood tumor, cardiovascular, urinary, endocrine system.
- •2)Subject who has history of surgical operation or diseases related to gastrointestinal symptom(e.g. crohn's disease, ulcer etc except appendectomy or simple for herina).
- •3)Subject who is hypersensitive to medicine containing component of mosapride, rebamipide or other medicine(asprin, antibiotics, etc.).
- •4)Subject who has hereditary problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
- •5)Subject who has one of following laboratory examination results.
- •- AST or ALT > 1.5 times of upper limit of normal range
- •- Total bilirubin > 1.5 times of upper limit of normal range
- •6)Subject who has hypertension or hypotonia, bradycardia or tachycardia in vital sign.
- •7)Subject who has medical history of use of drugs of abuse and/or tested positive findings on urinary drug screening.
- •8)Subject who takes drug metabolizing enzyme inducement or reducement drug such as barbiturates or takes food(grapefruit-containing juice)influence drug metabolism within 4 weeks before the first administration of the drug.
- •9)Subject who takes any ETC or oriental medicine within 3 weeks or takes any over-the-counter medication within 10 days(When other conditions is suitable for this study, according to the judgment of investigator, subject can participate in this study.)
- •10)Subject who has an experience in participating other clinical study within 3 months before the first administration.
- •11)Subject who donated whole blood within recent 2 months or donated components of blood within recent 1 month before initiation of this study
- •12)Subject who consistently intakes alcohol(>21 units/weeks, 1unit = 10g of pure alcohol)or can't stop drinking during the treatment period.
- •13)Subject who consistently smokes (> 10 cigarettes/day) or can't stop smoking during the treatment period.
- •14)Subject who estimated as an unsuitable subject for this study caused by clinical laboratory test and/or other reason by investigator.
- •15)Subject who can't use contraception during the study.
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