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
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
研究概览
简要总结
Enough volunteers shall be recruited in order to evaluate and start the study with at least 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-by subjects will be included to ensure successful dosing of 18 subjects in period I.
Demographic data, medical and medication history, physical examination, 12 lead ECG, haematology, biochemistry, serology, urine routine analysis and additionally for females serum pregnancy test, hormone assay (FSH) will be done within 21 days and chest X-ray within 06 months prior to check-in.
After collection of blood samples from all the subjects at each time point, study personnel will place the collected samples in a thermo-insulated box containing wet ice and transfer the box to the sample processing room where the blood samples will be centrifuged at 4000  50 RPM for 10 minutes at 02°C to 08°C to separate the plasma. Centrifugation will start within 30 minutes of the collection of samples, at each collection time-point. The resulting plasma will be equally transferred to pre-labeled polypropylene tubes into two aliquots.
Guanfacine in plasma will be assayed using a validated bio-analytical method.
The 90% confidence interval of the relative means of Cmax, AUC0-t and AUC0-inifinity 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 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).
排除标准
- •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.
结局指标
主要结局
To assess the oral bioavailability on Guanfacine for Extended-Release Suspension 4 mg
时间窗: 26 blood samples | 00.00 hrs 00.50 hrs 01.00 hrs 01.50 hrs 02.00 hrs 02.50 hrs 03.00 hrs 03.50 hrs 04.00 hrs 04.50 hrs 05.00 hrs 05.50 hrs 06.00 hrs 06.50 hrs 07.00 hrs 07.50 hrs 08.00 hrs 09.00 hrs 10.00 hrs 12.00 hrs 16.00 hrs 24.00 hrs 36.00 hrs 48.00 hrs 72.00 hrs 96.00 hrs
次要结局
- To monitor the safety & tolerability in healthy male & female adult human subjects under fed conditions(26 blood samples)
研究者
Dr PradeepT
Spinos life science and Research Pvt Ltd