A Double Blind Balanced Randomized Single Dose Three Arm Three Sequence Three Period Three Way Crossover Oral Pharmacokinetic Study Comparing Berberine HCl 40% with Natural Additives Berberine HCl 40% with Natural Additives and Probiotics and Berberine HCl 95% 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
- 36
- 试验地点
- 1
- 主要终点
- To assess and compare the Pharmacokinetics of three Berberine HCl Manufactured by India Glycols Ltd Plot 2 5 Selaqui 248197 Dehradun Uttarakhand India in Healthy Adult Human Subjects under Fasting conditions
研究概览
简要总结
At least 36 number of healthy adult human subjects will be recruited to evaluate the Pharmacokinetic of Test products
As per the discretion of the Investigator a sufficient number of stand by subjects will be included additionally to ensure successful dosing of 36 subjects in period I alone
In each period subjects will be housed in the clinical facility for at least 11.00 hours pre dose to 24.00 hours post dose
A washout period of at least 07 days will be maintained between each dosing period
In each period after an overnight fasting of at least 10.00 hours in the morning a single oral dose of either of the test products T will be administered as per the randomization schedule with 240 mL of drinking water at ambient temperature
Blood pressure, radial pulse rate body temperature and wellbeing status will be enquired and recorded at and 00.00 hour within 75 minutes of before dosing and at 01.00 03.00 06.00 and 12.00 hours ± 45 minutes post dose
Seated blood pressure radial pulse rate body temperature and wellbeing status will be enquired and recorded before the collection of the ambulatory sample at 36.00 and 48.00 hours ± 45 minutes post dose
Physical examination and vitals will be recorded before check in check out 24.00 hours ± 45 minutes for each period and at any time if necessary
Monitoring for adverse events will be done throughout the study period in clinical phase
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
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 adult human male and female subjects of age between 18 45 years and Body Mass Index BMI ranges between 18.50 kg/m2 to 24.
- •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 not limited to an evaluation of the cardiovascular gastrointestinal respiratory musculoskeletal and central nervous system and vital sign assessments Generally healthy as documented by a 12 lead electrocardiogram Chest X Ray and clinical laboratory assessments Willing to comply with all requirements of this study protocol as well as instructions from the study personnel Non smokers who have abstained from tobacco use for at least 6 months prior to screening Generally healthy as documented by gynaecological examination and breast examination period I only Healthy individuals who were not currently undergoing treatment for any serious disease Females of childbearing potential must have a negative serum pregnancy test performed within 21 days prior to the initiation of the study and a negative urine pregnancy test prior to check-in for each period If the 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 for eligible subjects only if applicable has a negative serum pregnancy test and is of non childbearing potential defined as greater than or equal to 1 year post menopausal no menstrual period for at least 12 consecutive months without any other medical cause Surgically sterile bilateral tubal ligation bilateral oophorectomy or hysterectomy or is of childbearing potential willing to commit to using a consistent and acceptable method of birth control as defined below for the duration of the study double barrier methods condoms cervical cap diaphragm and vaginal contraceptive film with spermicide or is of childbearing potential and not sexually active willing to commit to using a consistent and acceptable method of birth control as defined above for the duration of the study in the event the subject becomes sexually active.
排除标准
- •Evidence of allergy or known hypersensitivity to Berberine Hydrochloride or its inactive ingredients 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 Currently being treated for an infection with an antibiotic and or antiviral prescription medication and who used 01 month before check in Renal or liver impairment Any disease or condition that might compromise the haemopoeitic gastrointestinal renal hepatic cardiovascular Musculoskeletal respiratory central nervous system or any other body system including presence of Diabetes Mellitus and Psychosis History of alcohol addiction or abuse Consumption of caffeine and or xanthine containing products ie coffee tea chocolate caffeine containing sodas colas etc cigarettes and tobacco containing products for at least 48.00 hours prior to check in and throughout the entire study Consumption of alcohol and its products grapefruit and or its juice and poppy containing foods within 48.00 hours prior to clinic admission and throughout the entire study Subjects who have taken any prescription medications within 14 days prior to study check in and throughout the study and any over the counter medicinal products herbal medications supplements within 30 days prior to study check in and throughout the study Subjects who have taken any unusual diet for whatever reason eg low salt for 48.00 hours prior to dosing and throughout the study.
- •Subjects with a history of participation in any other clinical study within 90 days preceding check in History of difficulty in swallowing History of difficulty in accessibility of veins Positive results for urine screen of drugs of abuse in urine prior to check in of each period Positive results for alcohol test prior to check in of each period Any blood donation excess blood loss within 90 days of check in Ingestion of any hormonal agent at any time within 14 days prior to the start of the study check in Use of hormone replacement therapy for a period of 06 months prior to dosing Female subjects demonstrating a positive pregnancy screen Female subjects who are currently lactating Females are likely to become pregnant during the course of the study.
结局指标
主要结局
To assess and compare the Pharmacokinetics of three Berberine HCl Manufactured by India Glycols Ltd Plot 2 5 Selaqui 248197 Dehradun Uttarakhand India in Healthy Adult Human Subjects under Fasting conditions
时间窗: 15 Time Points | 00 00 Hrs 00 25 Hrs 00 50 Hrs 00 75 Hrs 01 00 Hrs 02 00 Hrs 03 00 Hrs 04 00 Hrs 06 00 Hrs 08 00 Hrs 12 00 Hrs 18 00 Hrs 24 00 Hrs 36 00 Hrs and 48 00 Hrs
次要结局
- To monitor the safety and tolerability of test products comparing in healthy adult human subjects under fasting conditions(15 Time Points)
研究者
Dr Pradeep T
Spinos Lifescience and research private limited