A Double Blind Balanced Randomized Single Dose Four Treatment Four Sequence Four Period Cross Over Oral Bioavailability Study To Compare Product A Zenroot Ashwagandha 8 % Product B Zenroot Ashwagandha 1.5% Product C KSM-66 Ashwagandha 5% And Product D Sensoril Ashwagandha 10% In Healthy Adult Human Subjects Under Fasting Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To compare the bioavailability of total withanolides from a single oral dose of Product A - Zenroot Ashwagandha 8%, Product B - Zenroot Ashwagandha 1.5%, Product C - KSM-66 shwagandha 5 and Product D - Sensoril Ashwagandha 10% in healthy adult human subjects under fasting conditions
研究概览
简要总结
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.
In each period subjects will be housed in the clinical facility for at least -24.00 hours pre-dose to 24.00 hours post-dose and the washout period of at least 05 days from the successive dosing day.
During the entire in-house stay from -24.00 hrs prior to dosing till 24.00 hrs post-dose, subjects will be served dinner on the day of check-in of each period. Standard diet will be served at around -23.00, -20.00, -16.00, -12.00 hrs pre-dose. Thereafter, subjects will be fasted for at least 10.00 hours prior to dosing and standard diet will be served at 04.00, 08.00 and 12.00 hours post-dose, in each period. All meal plans will be identical in all the periods of the study.
Subjects will be selected on the basis of abstinence from any prescription medications within 14 days prior to study check in and they will be instructed not to take any prescription medications throughout the study. Subjects will be instructed not to take any over the counter medicinal products, herbal medications throughout the study and they will be selected on the basis of abstinence from over the counter medicinal products, herbal medications including Ashwagandha 07 days prior to check-in of period-I till end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Normal, healthy, adult, human subjects (12 Males and 8 Females) of age between 18-55 years (both inclusive) and Body Mass Index (BMI) ranges between 20.00 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 Healthy as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, musculoskeletal and central nervous system) and vital sign assessments Generally healthy as documented by 12-lead electrocardiogram (ECG), Chest X-Ray and clinical laboratory assessments.
排除标准
- •Evidence of allergy or known hypersensitivity to Ashwagandha or its metabolites Subjects with hepatic encephalopathy cholestasis myasthenia pre-existing liver disease alcohol abuse existing tinnitus and pre-existing gallbladder disease 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.
结局指标
主要结局
To compare the bioavailability of total withanolides from a single oral dose of Product A - Zenroot Ashwagandha 8%, Product B - Zenroot Ashwagandha 1.5%, Product C - KSM-66 shwagandha 5 and Product D - Sensoril Ashwagandha 10% in healthy adult human subjects under fasting conditions
时间窗: 13 time points | 0.00 Hrs | 00.25 Hrs | 00.50 Hrs | 00.75 Hrs | 01.00 Hrs | 02.00 Hrs | 03.00 Hrs | 04.00 Hrs | 05.00 Hrs | 06.00 Hrs | 09.00 Hrs | 12.00 Hrs | and 24.00 Hrs
次要结局
- To compare the bioavailability of Withanoside IV, Withanolide A, 12 deoxywithanstramonolide and Withaferin A from a single oral dose of Product A - Zenroot Ashwagandha 8%, Product B - Zenroot Ashwagandha 1.5%, Product C - KSM-66 Ashwagandha 5% and Product D - Sensoril Ashwagandha 10% in healthy adult human subjects under fasting conditions(13 time points)