Comparative bioequivalence study of the Regorafenib 40 mg, tablet 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: 2024年3月6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 Pazopanib 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)
•Due to the possibility of QT prolongation complications, volunteers with a family history of heart diseases, especially rhythm disorders, are excluded from the study.

发起方

Kimia Noavaran Daroui