A double-blind taste evaluation study (gustatory sensation test) on 30mg formulations of Fexofenadine hydrochloride and comparison with the fexofenadine plain drug in healthy, adult male human subjects under normal conditions.

Sri Venkateshwara College of Pharmacy0 个研究点目标入组 12 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1) subjects aged between 18 to 45 both inclusive
•2) Subject weight +/- 15% of ideal weight chart of LIC of India for non medical cases
•3)Normal health as determined by personnel medical history and clinical examination
•4) Subjects able to communicate effectively
•5) Subjects willing to adhere to protocol requirements.

•1) hypersensitivity to fexofenadine HCl or related drugs
•2) History or presence of allergic rhinitis, asthma, urticaria, anaphylaxis
•3) History or presence of significant smoking (more than 10 cigarettes or bidis/day) or consumption of tobacco products
•4) History or presence of significant alcoholism or drug abues in the past one year
•5) History or presence of significant gastric and duodenal ulceration
•6)History or presence of significant sour tounge and oral ulcers
•7)History or presence of cancer
•8) Use of any prescribed medication during last tow weeks or OTC medical products during last one week preceding the first dosing
•9) Major illness during one month before screening
•10) Subjects who have been on an abnormal diet for whatever reason during the four week during the screening
•11) Participation in the drug research study within past 3 months
•12) Subjects who show sensitivity to the 1/10th concentration of standard quinine solution or super/non-taster by PROP method

发起方

Sri Venkateshwara College of Pharmacy