An Open Label Balanced Randomized Single Dose Three Treatment Three Sequence Three Period Three Way Crossover Oral Comparative Bioavailability Study Of Guanfacine For Extended Release Suspension 4 Mg Manufactured By Sciecure Pharma Inc (Subsidary Of Brillian Pharma Inc) With Intuniv (Guanfacine Hydrochloride) 4 Mg Extended Release Tablets Manufactured By Takeda Pharmaceuticals USA In Healthy Male And Female Adult Human Subjects Under Fed Conditions - NI

Sciecure Pharma Inc0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

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•Normal healthy Male and Female adult human subjects of age between 18-45 years and Body Mass Index (BMI) ranges between 18.50 kg/m2 to 29.99 kg/m2
•Subjects who have no evidence of underlying disease during screening and check-in
•Subjects whose screening laboratory values are within normal limits or considered by the physician or principal/clinical investigator to be of no clinical significance
•Generally healthy as documented by 12-lead electrocardiogram (ECG) Chest x Ray and clinical laboratory assessments
•Willing to consume non-vegetarian diet
•Non- smokers
•Healthy as documented by gynecological examination and breast examination
•Females of childbearing potential must have a negative serum pregnancy test performed within 21 days prior to initiation of the study and a negative urine pregnancy test prior to check-in of each period
•If subject is female currently not pregnant not lactating or not attempting to become pregnant for 4 weeks before the screening visit, throughout the duration of the study and 3 weeks after the subjects last study-related visit
•Childbearing potential willing to commit to using a consistent and acceptable method of birth control by double barrier method and IUD (intrauterine device)

•Evidence of allergy or known hypersensitivity to Guanfacine or its inactive ingredients
•Subjects with hepatic encephalopathy cholestasis myasthenia pre existing liver disease alcohol abuse existing tinnitus and pre existing gallbladder disease and Renal or liver impairment
•Presence of Diabetes Mellitus and Psychosis
•History of alcohol addiction or abuse
•Consumption of caffeine or Xanthine containing products alcohol grape juice and poppy containing foods within 48 hours prior to clinic admission and throughout the entire study
•History of difficulty in swallowing and inaccessibility of veins
•Female subjects demonstrating a positive pregnancy and are currently lactating

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