A randomized, open-label, single-dose, 2-way cross-over study to compare the safety and the pharmacokinetic characteristics of the co-administration of telmisartan and rosuvastatin and YH16410 in healthy volunteers

Yuhan0 个研究点目标入组 180 人开始时间: 待定最近更新: 2019年3月11日

试验速览

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•1)Healthy male and female aged 20 to 50.
•2)Who has no congenital or chronic medical history and whose results of physical examination are not clinically significant.
•3)Who voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written informed consent form.

•1)Who has disease or history of clinically significant disease.
•2)Whose Sitting blood pressure meeting clinically abnormal.
•3)Whose history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.
•4)Who has administered other investigational products within 90 days prior to the first dosing.
•5)Who has administered herbal medicine within 28 days or ethical drugs within 14 days or over-the-counter (OTC) drugs within 7 days prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study).
•6)Whose Aspartate aminotransferase(AST) or/and Alanine aminotransferase(ALT) level > 3 times of normal upper limit at the time of screening.
•7)Whose Creatine kinase(CK) level > 5 times of normal upper limit at the time of screening.
•8)Who suffering from moderate or severe renal failure with damaged renal (Glomerular filtration rate(GFR) <60 ml/min/1.73m^2).
•9)Who considered not eligible for the clinical trial by the investigator (study do

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