Comparative bioequivalence study of the Omeprazole 10-mg Sachet manufactured by Nafas Zist Pharmed Pharmaceutical Company

afas Zist Pharmed Pharmaceutical Company0 个研究点目标入组 24 人开始时间: 待定最近更新: 2023年5月29日

试验速览

暂无简介。

•The weight range of participating candidates should be between 60-100 kg
•All candidates must be non-smokers
•Candidates should be healthy in terms of physical examination, ECG and the following laboratory tests: Hemoglobin, Hematocrit, Red and White Blood Count, MCV (Mean Body Volume), MCH (Mean Body Hemoglobin), Routine Urinalysis, Total Cholesterol, Triglyceride, Total Proteins, albumin, uric acid, total bilirubin, alkaline phosphatase, gamma glutamyl transpeptidase (?-GT), aspartate aminotransferase (AST), alanine aminotransferase (ALT), urea, creatinine and fasting blood glucose
•Volunteers who have agreed to an informed consent form
•All candidates should not consume caffeine-containing drinks and chocolate during two days before the prescription, and this restriction must be followed until the last blood draw

•History of allergic or adverse reaction to Esomeprazole or any similar product
•Volunteers with blood pressure less than 60/90 mm Hg or higher than 90/140 mm Hg
•Individuals who donated whole blood or blood components within 2 months within 2 weeks prior to the first dose of the study product(s)
•Patients with neutrophil count less than 500 cells/mm3
•Patients with lymphocyte count less than 500 cells/mm3
•Patients with serious infection (e.g., sepsis) or active infection, including local infection

发起方

afas Zist Pharmed Pharmaceutical Company