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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- To assess the oral bioavailability on Guanfacine For Extended-Release Suspension 4 mg with Intuniv 4.g extended release tablets
研究概览
简要总结
Enough volunteers shall be recruited in order to evaluate and start the study with atleast 18 subjects, as this Bioavailability study will be conducted on healthy, male &female adult, human subjects.
As per the discretion of Investigator, additionally a sufficient number of stand-bysubjects will be included to ensure successful dosing of 18 subjects in period 1.
Demographic data, medical and medication history, physical examination, 12 lead ECG, haematology, biochemistry, serology, urine routine analysis and additionallyfor females serum pregnancy test, hormone assay (FSH) will be done within 21days and chest X-ray within 06 months prior to check-in.
The 90% confidence interval of the relative means of Cmax, AUCo-t for Guanfacine of the test and reference product should be between 80.00% and 125.00% for Ln-transformed data
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
To assess the oral bioavailability on Guanfacine For Extended-Release Suspension 4 mg with Intuniv 4.g extended release tablets
时间窗: 26 blood samples | 00.00 hours, 00.50 hours, 01.00 hours, 01.50 hours, 02.00 hours, 02.50 hours, 03.00 hours, 03.50 hours, 04.00 hours, 04.50 hours, 05.00 hours, 05.50 hours, 06.00 hours, 06.50 hours, 07.00 hours, 07.50 hours, 08.00 hours, 09.00 hours, 10.00 hours, 12.00 hours, 16.00 hours, 24.00 hours, 36.00 hours, 48.00 hours, 72.00 hours and 96.00 hours
次要结局
- To monitor the safety and tolerability of Gunafacine in healthy male and female adult human subjects(26 blood samples)
研究者
Dr Pradeep T
Spinos Lifescience and Research Private Limited