A Randomized, Open-label, Multiple Dose, Two-treatment, Two-period, Two-sequence Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Mosapride Citrate and Rebamipide After Oral Administration in Healthy Volunteers

IlDong Pharmaceutical Co Ltd1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2013年5月最近更新: 2014年4月8日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: IlDong Pharmaceutical Co Ltd
入组人数: 40
试验地点: 1
主要终点: AUCτ,ss of Mosapirde citrate 5mg

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The investigators investigate the potential pharmacokinetic drug-drug interaction between Mosapride citrate 5 mg and Rebamipide 100 mg in healthy male volunteers who receive Mosapride citrate 5 mg, Rebamipide 100 mg, and both together in a 2 period repeatedly.

详细描述

To evaluate the safety, drug-tolerance, pharmacokinetics of Mosapride citrate 5 mg or Rebamipide 100 mg monotherapy or Mosapride citrate 5 mg and Rebamipide 100 mg combination in healthy male subjects.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: None

入排标准

年龄范围: 20 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy volunteers, age 20 to 45 years
•Body weight ≥ 55kg (male), ≥ 50kg (female)
•Body weight index (BMI) 18.5 ~ 25
•Acceptable serum test, hematologic test, blood chemistry examination, urin test and ECG, physical examination during screening
•Subject decided to participate voluntarily and gave written Informed consent to comply with the instructions after listening to and fully understanding the detailed explanation about this trial.

排除标准

•Subject has clinically significant liver, kidney, neurologic, immunologic, respiratory, endocrine disease or hematologic·oncologic disease, cardiovascular disease or psychiatric disease (mood disorder, compulsive disorder etc.) or such medical history (including subject with hepatitis virus in case of liver disease).
•Subject has history of gastrointestinal disease (such as Crohn's disease, ulcer, acute or chronic pancreatitis etc.) or gastrointestinal surgery (except simple appendectomy or hernia operation) that can affect the absorption of the study drug.
•Subject has hypersensitivity reaction to drug (aspirin, antibiotics, including study durgs, etc.) or history of clinically significant hypersensitivity reaction.
•Systolic blood pressure > 150mmHg or <90mmHg, Diastolic blood pressure >100mmHg or <50mmHg(Sitting blood pressure) during the screening procedure
•Subject has history of drug abuse or tested positive to abused drug in the urine drug screening test.
•For women, pregnant or breastfeeding woman or woman who was confirmed to be pregnant in the pregnancy test
•Subject takes caffeine-containing food 5 cups per day
•Subject continually drinks (in excess of 210g/week)
•Subject smokes 10 cigarettes or more in one day
•Subject took any prescribed drug or oriental medicine within 2 weeks prior to the first medication or any over-the-counter (OTC) drug within 1 week prior to the first medication (however, the subject can be included if other criteria are met according to the discretion of the investigator).
•A subject who takes grapefruit, grapefruit juice, or grapefruit-containing products within 30 days prior to the first dosing
•Subject participated in another study and received medication within 2 months prior to the first medication day.
•Subject received whole blood transfusion (500 mL) within 2 months prior to the first medication or blood transfusion within 1 month prior to the first medication.
•Subject was judged not to be eligible according to the discretion of the investigator for other reasons.