A comparative Bioavailability study of Berberine in Healthy Volunteers.
- Registration Number
- CTRI/2023/10/058210
- Lead Sponsor
- Akay Natural Ingredients Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Healthy volunteers who are not involved in any regular medication or supplementation.
2.Females of child bearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening.
3.Subject understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study.
1.Subjects who have consumed Berberine containing food/supplements 2 days prior to screening.
2.Subjects having symptoms of viral infection.
3.Pregnant or lactating women.
4.Subjects with known hypersensitivity to the investigational products.
5.Subjects who have participated in any clinical trial in the past 1 month.
6.Any subjects found to have entered in to the study in violation of this protocol or if the subject is uncooperative during the study.
7.Any other condition that in the opinion of the investigator that does not justify the subject’s participation in the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To estimate the concentrations of formulated Berberine (FBBN-10-23) in comparison with normal unformulated Berberine (UFBBN-10-23) supplementation.Timepoint: Period 1, Period 2, Period 3, Period 4
- Secondary Outcome Measures
Name Time Method Pharmacokinetic parameters of FBBN-10-23 in comparison with UFBBN-10-23 supplementation.Timepoint: Period 1, Period 2, Period 3, Period 4;The safety and tolerability of FBBN-10-23 in comparison with UFBBN-10-23 supplementation.Timepoint: Period 1, Period 2, Period 3, Period 4