Comparative bioequivalence study of Domperidone 10 mg F.C. Tablet of ACTOVERCO and Janssen Inc. in 24 healthy male under fasting

ACtover Pharmaceutical Co.0 个研究点目标入组 26 人开始时间: 待定最近更新: 2021年11月1日

试验速览

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•Healthy subjects should be between 18 – 45 years of age and their Body Mass Index (BMI) should be in the normal range according to the accepted average 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.
•Have a ECG and normal vital signs.
•Subjects who agree with the patient consent form.

•History of allergy or iosyncrasy to domperidone or any of the inactive components of the formulation.
•If you have or have a history of arrhythmia, including tachycardia or ventricular fibrillation, increased QT interval, bradycardia, or heart failure.
•Identify electrolyte disturbances and water loss due to diarrhea, vomiting or other causes 24 hours before the study.
•Bleeding or obstruction of the gastrointestinal tract during the last 6 weeks.
•In case of acute or chronic diseases related to the cardiovascular, respiratory, gastrointestinal, endocrine, blood and kidney or liver failure systems.
•Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period.
•Subjects who have 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 the study period.
•History of alcohol or drug abuse within 5 years before the start of the study.
•Heavy drinker of caffeine, grapefruit juice, or caffeinated drinks or who are on a special diet (such as vegetarians) or do exertional physical activity.
•A history of difficulty with donating blood or donation of more than 450 ml blood within 60 days prior to the start of the study.

发起方

ACtover Pharmaceutical Co.