Comparative bioequivalence study of the Fexofenadine HCl suspension 30mg/5ml manufactured by Amin Company

Amin Pharmaceutical Co0 个研究点目标入组 24 人开始时间: 待定最近更新: 2024年7月22日

适应症

试验速览

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•The weight range of participating candidates should be between 60-100 kg
•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 Fexofenadine HCl 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)

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