Randomized, single-dose, crossover comparative bioavailability study of the Marhamdarou zolpidem versus Stilnoct (Sanofi Company) in 24 healthy males under fasting conditions

Marham daru0 个研究点目标入组 24 人开始时间: 待定最近更新: 2019年1月14日

适应症

试验速览

暂无简介。

•healthy subjects with BMI 18.5-30 kg/m2
•Not having a history of any significant disease or any abnormal finding in laboratory examination or during physical examination
•Not physical or psychological dependence to narcotics

•Known hypersensitivity to zolpidem or any ingredients.
•Obstructive sleep apnea
•Ingestion of a medicine (even herbal medicines), drugs for abuse or cigarette at any time within 7 days before dosing in Period-I (before the beginning of the study)
•History of any problem in blood donation
•Consumption of alcohol, grapefruit juice or caffeinated drinks 24 hours prior to the drug administration.
•Myasthenia gravis
•Severe hepatic insufficiency
•Acute and/or severe respiratory depression
•Any diseases that interacting with ADME (Absorption, Distribution, Metabolism & Excretion) procedures
•Psychotic illnesses
•Blood loss (>200 ml) during recent 60 days

发起方

Marham daru