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 Fasting Conditions - NI

Brillian 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 and whose screening is performed within 21 days of 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 Ovo lacto vegetarian diet
•Willing to comply to all requirements of this study protocol as well as instructed
•by the study personnel
•Non Smokers
•Generally healthy as documented by gynaecological examination and breast
•examination
•Females of childbearing potential must have a negative serum and urine pregnancy test
•performed within 21 days prior to initiation of the study

•Evidence of allergy or known hypersensitivity to Guanfacine or its inactive ingredients
•Any major illness in the last three months or any significant ongoing chronic medical illness
•Renal or liver impairment
•Any disease or condition which might compromise the haemopoeitic gastrointestinal renal hepatic cardiovascular musculoskeletal respiratory central nervous system Or any other body system presence of Diabetes Mellitus and Psychosis
•History of alcohol addiction or abuse
•Consumption of caffeine and or Xanthine containing products cigarettes and tobacco containing products for at least 48.00 hours prior to check-in and throughout the entire study
•Subjects who have taken an unusual diet for whatever reason (eg low salt) for 48.00 hours prior to dosing and throughout the study
•History of difficulty in swallowing and accessibility of veins
•Positive results for urine screen of drugs of abuse and alcohol test in urine prior to check in of each period
•Female subjects demonstrating a positive pregnancy screen and who are currently lactating

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