A Single Dose Two-Way Crossover Oral Bioavailability Study Of The Study Product (BerbiQ) Which Contains Berberine, In Healthy, Adult, Human Subjects Under Fasting Conditions.
- Registration Number
- CTRI/2024/07/070781
- Lead Sponsor
- Molecules Biolabs Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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/m2.
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.Timepoint: pre dose and at 00.50, 01.00, 02.00, 06.00,12.00, 24.00 and 48 hours.
- Secondary Outcome Measures
Name Time Method To monitor the adverse events and to ensure the safety of the subjects.Timepoint: screening and end of study.