A randomized, open-label, multiple-dose, crossover study to investigate the pharmacokinetic drug interaction between rosuvastatin and telmisartan in healthy volunteer

Yuhan0 个研究点目标入组 48 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 with a body mass index(BMI) between 19 and 27 kg/m2
•2. Acceptable medical history, physical examination, laboratory tests and EKG, during screening
•3. Provision of signed written informed consent

•1.History of and clinically significant disease
•2.Sitting blood pressure meeting the following criteria at screening:
•150 = systolic blood pressure =90 (mmHg) and
•95 = diastolic blood pressure = 50 (mmHg) amd
•100 = Heart rate = 40
•3. A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.
•4. Administration of other investigational products within 90 days prior to the first dosing.
•5. Administration of herbal medicine within 30 days or administration of ethical drugs within 14 days or administration of 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.Have AST(SGOT) or/and ALT(SGPT) > 3 times of normal upper limit at the time of screening
•7. Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.

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