Comparative bioequivalence study of Tamsulosin 0.4 mg ER Capsule of Cosar Pharmaceutical Co. and ? Omnic of astellas in 24 healthy male under fasting.

Cosar pharmaceutical Co.0 个研究点目标入组 24 人开始时间: 待定最近更新: 2022年6月27日

试验速览

暂无简介。

•Healthy Subjects should be between 20-45 years old.
•Body Mass Index (BMI) within 15% of normal range 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 must have normal vital signs.
•Subjects agree to all clinical study requirements based on clinical study guidelines that have been approved by accepting the informed consent form.

•History of known allergies to test products.
•Subject with a history of neoplastic disease (cancer), stroke, chronic seizures or major neurological disorder, clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases.
•Smokers who smoke more than 10 cigarettes a day and have trouble not smoking during each clinical study 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.
•People who have a history of alcoholism or alcohol consumption in the past 2 years.
•Heavy drinker of caffeine, grapefruit juice or caffeinated drinks.who are on special diet (such as vegetarians).
•Who 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

Cosar pharmaceutical Co.