Comparative bioequivalence study of the Dapagliflozin 10-mg tablets manufactured by Noavaran Daroui Kimia Company

KIMIA Noavaran Daroui0 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 must be between 60-100 kg.
•All candidates must be non-smokers.
•The candidates must be healthy in terms of physical examination, ECG and the following laboratory tests: hemoglobin, hematocrit, red and white blood count, MCV ( mean body mass), MCH (mean body hemoglobin), routine urinalysis, total cholesterol, triglycerides, total proteins, albumin, uric acid, total bilirubin, alkaline phosphatase, gamma glutamyl transpeptidase (?-GT), amino aspartate transferase (AST), alanine aminotransferase (ALT), urea, creatinine and fasting blood glucose.
•Volunteers who agreed to the informed consent form.

•History of allergic or adverse reaction to dapagliflozin or any similar product.
•Volunteers with blood pressure less than 60/90 mm Hg or higher than 90/140 mm Hg.
•People who 10 days before the first day of consumption, Drug-experienced
•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

KIMIA Noavaran Daroui