An open-label study to evaluate the effect of amoxicillin/clavulanate on the pharmacokinetics of valproic acid in healthy adult volunteers

Samsung Medical Center0 个研究点目标入组 16 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。

•1) Adult male aged 19 to 55 years at screening
•2) A body mss index between 19 and 27 kg/m2 at screening
•3) A subject who is able to understand the study, and to provide written informed consent voluntarily after being fully informed of the study objectives, procedures and study drug
•4) A subejct who is able to participate the whole study period

•1) A subject who has the medical history of or has the clinically significant hepatobiliary, renal, gastrointestinal, respiratory, musculoskeletal, endocrinal, hemato-oncologic, or cardiovascular disease
•2) A subject who has systolic blood pressure < 90 or = 150 mmHg and/or diastolic blood pressure < 60 or = 100 mmHg
•3) A subject with a history of allergies to valproic acid, amoxicillin, or other drugs (e.g., aspirin, antibiotics)
•4) A subject who received any study drug within 60 days before the first drug administration
•5) A subject who has donated whole blood or blood components within 60 days or 30days, respectively, or has been transfused blood within 30 days
•6)A subject who has taken the drug or food which can inhibits or induces CYP or UGT (e.g., indinavir, ritonavir, fluconazole, ketoconazole)
•7)A subject who consumes alcohol more than 140 g per week or who cannot stop drinking during the admission period
•8)A subject who smokes more than 10 cigarettes per day or who cannot stop smoking during the admission period
•9)A subject of positive result in serology tests (HBV, HCV, HIV)
•10)A subject who has the AST or ALT > 1.5 times of upper normal limit
•11) A subject who has the glomerular filtration rate (GFR) calculated by plasma creatinine values < lower normal limit
•12) A subject who is inadequate for the clinical trial by the investigator’s decision

发起方