Randomized, single-dose, crossover comparative bioequivalence study of Gliclazide 30 mg MR tablet of ACTOVERCO and Servier Inc. in 24 healthy male under fasting conditions

ACtover Pharmaceutical Co.0 个研究点目标入组 24 人开始时间: 待定最近更新: 2024年1月22日

适应症

试验速览

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•Healthy subjects (male) between 20 – 45 years of age and Body Mass Index (BMI) within 15% of normal range according to the accepted normal values between 18.5 and 30 (inclusive), calculated as kg/m2.
•Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations.
•Subjects with normal vital signs.
•Subjects who agree with patient consent form.

•Subject has a history of significant asthma, peptic or gastric ulcer, sinusitis, pharyngitis, renal disorder (impaired renal function), hepatic disorder (impaired hepatic function), cardiovascular disorder, neurological disease such as epilepsy, hematological disorders or diabetes, psychiatric, dermatologic or immunological disorders.
•Acute infection within one week preceding first study drug administration.
•A known hypersensitivity to gliclazide or its analogues.
•Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period.
•Subjects who has used any drug including prescription or Over-The-Counter (OTC) drugs within 14 days prior to the start of the study and might need drug intake during study period.
•History of alcohol or drug abuse within 2 years before the start of the study.
•Heavy drinker of caffeine, grapefruit juice or caffeinated drinks or who are on special diet (such as vegetarians) or do exertional physical activity.
•A history of difficulty with donating blood or donation of more than 500 ml blood within 7 days prior to the start of the study.

发起方

ACtover Pharmaceutical Co.