A Double-Blind, Randomized, Single Dose, Two-Treatment, Two-Way Crossover, Oral Bioavailability Study of Investigational Product (Berbiq) Containing Berberine, 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
- 10
- 试验地点
- 1
- 主要终点
- To evaluate the oral bioavailability of investigational product 250 mg of Berberine Capsule) of Molecules BioLabs Private Limited, and the reference product 250 mg of conventional Berberine capsule of Molecules BioLabs Private Limited in healthy, adult, human subjects under fasting conditions.
研究概览
简要总结
The risk of developing the metabolic syndrome, and its course severity, can be reduced by eliminating risk factors, such as an inappropriate diet, physical inactivity, stress, anxiety-depressive disorders, personality disorders, and the resulting behavioral addictions. The fight against this complex disease also involves the treatment of identified dis- orders within the metabolic syndrome, such as atherogenic dyslipidemia (hypertriglyceridemia and lowering LDL cholesterol), as well as the treatment of the repercussions of the metabolic syndrome, such as atherosclerosis, diabetic feet, liver cirrhosis due to non-alcoholic or alcoholic steatohepatitis, acute or chronic pancreatitis, local or general immunodeficiencies, and tendency for recurrent infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator 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
- •1.Normal, healthy, adult, male and female Human participants of age between 18-45 years with a Body Mass Index range between 18.50 kg/m2 to 24.99 kg/m
- •2.Subject agrees to avoid high activity physical exercise 72.00 hours prior to last visit 3.Subjects who have no evidence of underlying disease during screening and check- in and whose screening is performed within 29 days of check in. 4.Subjects generally healthy as documented at screening considered by the physician or principal or clinical investigator. 5.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 systems and vital sign assessments. 6.Non- smokers or ex-smokers. Ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months. 7.Willing to comply to all requirements of this study protocol as well as instructed by the study personnel 8.Generally healthy as documented by gynecological examination and breast examination -for female subjects during Period-I check-in only. 9.Female subjects of childbearing potential; a.Practicing an acceptable non-hormonal contraceptive method of birth control after consulting with principal investigator; and/or b.Surgically sterile.
- •bilateral tubal ligation.
排除标准
- •1.Evidence of allergy or known hypersensitivity to Berberine or other related drugs or other related drugs.
- •2.Subjects with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver disease, alcohol abuse, existing tinnitus, renal or liver impairment and pre-existing gallbladder disease.
- •3.Any major illness in the last three months or any significant ongoing chronic medical illness.
- •4.Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, Musculoskeletal, respiratory, central nervous system, diabetes, psychosis or any other body system.
- •5.History of alcohol addiction or abuse.
- •6.Malabsorption syndrome that affects Berberine metabolism.
- •7.Heart failure, angina pectoris, ventricular arrhythmias or atrial fibrillation with more than100 per min ventricular rate.
- •8.Gastrointestinal bleeding in past three months.
- •9.Uncontrolled diabetes mellitus.
- •10.Active psychiatric disorder, intention for suicidal, disorders with Unconsciousness.
- •11.Psychopathic disorder, lack of cooperation.
- •12.Chronic obstructive lung disease or active smoking -more than 2 cigarettes in the past 6 months 13.Consumption of caffeine and or Xanthine containing products i.e., coffee, tea, chocolate, and caffeine-containing sodas, colas, etc., tobacco containing products for at least 24.00 hours prior to check-in and throughout the entire study 14.Consumption of grapefruit and its juice and poppy containing foods for at least 72.00 hours prior to check-in and throughout the study.
结局指标
主要结局
To evaluate the oral bioavailability of investigational product 250 mg of Berberine Capsule) of Molecules BioLabs Private Limited, and the reference product 250 mg of conventional Berberine capsule of Molecules BioLabs Private Limited in healthy, adult, human subjects under fasting conditions.
时间窗: pre dose and at 00.50, 01.00, 02.00, 06.00,12.00, 24.00 and 48 hours.
次要结局
- To monitor the adverse events and to ensure the safety of the subjects.(screening and end of study.)
研究者
Dr Ambanna Gowda
Unitree Health Care Diagnostics