A randomized, open-label, single dosing, three-way crossover clinical trial to investigate the pharmacokinetic drug-drug interaction of Cilnidipine 10 mg and Valsartan 160 mg after oral administration in healthy male volunteers

Ildong pharmaceutical0 个研究点目标入组 54 人开始时间: 待定最近更新: 2019年3月11日

试验速览

阶段: 未知
状态: 已完成
发起方: Ildong pharmaceutical
入组人数: 54

研究概览入排标准研究者记录与标识符相似试验

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 40(Year)（—）
性别: Male

入选标准

•1) Healthy male volunteers, age 20 to 40 years
•2) The result of Body Mass Index(BMI) is not less than 18.5 kg/m2 , no more than 25 kg/m2 and body weight are least 55 kg
•3) Subjects who have no congenital or chronic disease and no abnormal symptom or opinion
•4) Acceptable serum test, hematologic test, blood chemistry examination, urin test and ECG, physical examination during screening
•5) Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

排除标准

•1) A subject with clinical evidence or history of hepatic (including carrier of hepatitis virus), renal, respiratory, endocrine, neurologic, immunologic, hematologic, oncologic, psychiatric, or cardiovascular disease
•2) A subject with a history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug
•3) A subject with history of drug allergies (aspirin, antibiotics, including study drug etc.), or history of clinically significant allergies
•4) Systolic blood pressure <100mmHg or Diastolic blood pressure < 60 mmHg, systolic blood pressure = 150 mmHg or diastolic blood pressure = 100mmHg(Sitting blood pressure) during the screening procedure.
•5) Presence or history of drug abuse or positive result in urine drug screening test
•6) Use any prescriptive medication, Korean traditional medication not considered acceptable by the clinical investigator during the last 14 days period before first dosing, or use any OTC medication not considered acceptable by the clinical investigator during the last 7 days period before first dosing (if used medication is considered acceptable by investigator, patients can be included)
•7) Participation in clinical trials of any drug within 60 days prior to the participation of the study
•8) Blood donation during 2 months or apheresis during 1 month before the study
•9) Use of alcohol over 21 units/weeks
•10) Smoker who smoke more than 20 cigarettes per day
•11) A subject who takes grapefruit, grapefruit juice, or grapefruit-containing products within 3 days prior to the participation of the study
•12) A subject who takes St John's wort or some food including the ingredient within 14 days prior to the participation of the study
•13) Judged to be inappropriate for the study by the investigator after reviewing clinical laboratory results or other reasons.

研究者

发起方

Ildong pharmaceutical

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