Randomized, single-dose, crossover comparative bioequivalence study of Omeprazole 20 mg tablet of ACTOVERCO and Hexal 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6月24日

适应症

试验速览

暂无简介。

•Healthy subjects (male) should be between 20-45 years old.
•subjects how have body mass index (BMI) Within 15% of normal range between 18.5-30 (Kg/m2)
•Subjects with normal vital signs.
•Subjects who agree with patient consent form.

•Subjects with known allergy to the products tested.
•Subjects must not have a historical specific diseases or abnormal values in labratory tests and general clinical examination.
•Chronic or acute diseases of the digestive system, such as diseases related to the esophagus, gastritis, peptic ulcer, intestinal inflammation, bleeding in the digestive tract, or digestive system surgery during the last three years.
•Having problems with vascular system, endocrine system, nervous system, digestive system, respiratory system, blood system, immune system, mental and metabolic system.
•Performing surgery within 4 weeks before drug administration or at the time of clinical study.
•Smoking more than 10 cigarettes per day, losing more than 500 ml of blood in less than 7 days.
•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.