Pharmacokinetic Study of rosuvastatin to Evaluate the Effect of Green Tea on the Organic anion Transporting Peptide (OATP)2B1

Konkuk University Medical Center0 个研究点目标入组 13 人开始时间: 待定最近更新: 2019年3月11日

试验速览

暂无简介。

•1) Adult aged 20-55
•2) Subject who can restrict diet including green tea or fruit juice
•3) Subject who gave an written informed consent by listening to the purpose of study, content of study and investigational drug

•1) Subject who has or had a clinically significant abnormality in liver, kidney, respiratory, muscle&skeletal, psychiatric, hemato-oncology or cardiovastular systems
•2) Subject who has a history of significant allergic reaction to rosuvastatin or drug of same class to rosuvastatin, to catechin or to other drugs(aspirin, antibiotics, etc.
•3) Subject who received other investigational drug within 60 days from screening
•4) Subject who donated whole blood within 60 days from screening or blood component within 30 days from screening
•5) Subject who received drugs or food which induce or inhibit organic anion-transporting polypeptide (OATP) or breast cancer resistance protein (BCRP)-gemfibrozil, cyclosporin, lopinavir/ritonavir etc.- within 2 weeks from screening
•6) Subject who drinks alcohol >140 g/week
•7) Subject who smokes >20 cigarettes/day
•8) Subject whose serology test(HBV, HCV or HIV) is positive
•9) Subject whose AST, ALT or total bilirubin is > 1.5 folds of upper normal limit
•10) Subject whose glomerular filtration rate (GFR) estimated by Modification of Diet in Renal Disease (MDRD) equation is below normal range
•11) Subject whose systolic blood pressure is <=90 mmHg or>=160 mmHg or diastolic blood pressure is <=50 mmHg or>=100 mmHg
•12) Subject who is judged inadequate by investigators for other reasons.

发起方