Bioavailability and Pharmacodynamic study (phase1) of Disgren EC capsule(Triflusal 300mg)

Kyungpook National University Hospital0 个研究点目标入组 38 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

暂无简介。

•Healthy male subjects between the ages of 20 and 55 years at screening;
•No abnormal symptom or sign, based on medical history and physical examination, with no congenital or chronic disease that requires treatment;
•Subject that is considered eligible for participating in the study by an investigator, based on clinical laboratory test (hematology, clinical chemistry, urinalysis, etc.);
•Hemorrhagic tendencies from medical history.

•Use of barbital drugs or alcohol abuse within 1 month prior to the study initiation;
•Use of drugs disrupting this study within 10 days prior to the study initiation;
•Medical history of clinically significant hypersensitivity to study drug;
•Subject that is not eligible to participate at this study, based on discretion of study investigator;
•Clinical abnormalities at clinical laboratory test.
•- The levels of aspartate aminotransferase (serum glutamic oxaloacetic transaminase) or alanine aminotransferase (serum glutamic pyruvic transaminase) > 1.25 x the upper limit of normal
•- The levels of Total bilirubin > 1.25 x the upper limit of normal
•- Platelet count(<180,000 or >350,000)
•- prothrombin time (PT), activated partial thromboplastin time (aPTT) , and bleeding time (BT) > normal

发起方