Comparative bioequivalence study of Hydrochlorothiazide 50 mg Tablet of Karen. and APO-HYDRO® of Apotex INC as reference in 24 healthy male under fasting.

Karen Pharma and Food Supplement Co.0 个研究点目标入组 24 人开始时间: 待定最近更新: 2023年11月13日

试验速览

暂无简介。

•Healthy volunteers
•Between 18 – 45 years of age and
•Body Mass Index (BMI) within 15% of normal range according to the accepted normal values between 18 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 with a history of known hypersensitivity to hydrochlorothiazide or other sulfonamide drugs, associated acute or chronic infections;
•Volunteers who have water and electrolyte disorders, including low blood potassium and sodium, history of diarrhea or vomiting, headache, muscle cramps or weakness in the past two weeks;
•blood pressure in standing position and after at least 5 minutes of rest, systole less than 100 or more than 140 mmHg and diastole less than 60 or more than 90 mmHg);
•Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period;
•volunteers with a history of difficulty with donating blood;
•donation of more than 500 ml blood within 7 days prior to the start of the study;

发起方

Karen Pharma and Food Supplement Co.