Comparative bioequivalence study of the Nicorandil 20-mg tablets manufactured by Modava Pharmaceoutical company

Modava Pharmaceutical Company0 个研究点目标入组 24 人开始时间: 待定最近更新: 2023年2月7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

•History of allergic or adverse reaction to nicorandil or any similar product
•Volunteers with blood pressure less than 60/90 mm Hg or higher than 90/140 mm Hg.
•People who have participated in other clinical studies or bioequivalence studies within 3 months before the first day of use
•Individuals who donated whole blood or blood components within 2 months within 2 weeks prior to the first dose of the study product(s)

发起方

Modava Pharmaceutical Company