A Bioequivalence Study of Two Formulations of 500-mg Levetiracetam Tablets in Healthy Thai Subjects under Fasting Conditions

T.O. Chemicals (1979) Ltd.0 个研究点目标入组 24 人开始时间: 2020年1月23日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1.Male/Female must be 18-55 years of age, body mass index (BMI) = 18.0-25.0 kg/m2, inclusive.
•2.Must be in good health
•3.Screening ECG without clinically significant abnormalities
•4.Screening visit laboratory values of blood test including hematology (complete blood count (CBC) with differential), fasting blood sugar (FBS), blood urea nitrogen (BUN), creatinine (Cr) analysis and liver function test (aspartate aminotransferase (AST)/alanine aminotransferase (ALT), total bilirubin and alkaline phosphatase (ALP)) must be within the normal range or showing no clinically significant abnormalities in the opinion of clinical investigator.
•5.Urinalysis results within normal limit or showing no clinically significant abnormalities in the opinion of clinical investigator.
•6.Must have serum hepatitis B surface antigen (HBsAg) seronegative and hepatitis C antibody (anti-HCV) negative.
•7.Non-smokers (never smoked or no smoking within the previous 1 year).
•8.Subjects must have ended any medications at least 30 days prior to Day 1 and agree to continue their refraining throughout the follow up period.
•9.Have the ability to understand the requirements of the study and must voluntarily sign and date an informed consent, approved by an Independent Ethic Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures

•1.Known hypersensitivity to levetiracetam and its components
•2.Past medical history of renal and hepatic insufficiency.
•3.Alcohol abuse or excessive use (in the opinion of the investigator, as judged by medical history) in the last 12 months.
•7.Have positive alcohol breathing test at screening visit or before dose administration at each period.
•8.Participation in any investigation drug study within 1 month from screening (from the last follow-up visit to the screening).

发起方

T.O. Chemicals (1979) Ltd.