A comparative Bioavailability study of Berberine in Healthy Volunteers.

A randomized, single-dose, double-blind, 4-way crossover, 4 sequence study to assess the bioavailability of formulated Berberine (FBBN-10-23) in comparison with normal unformulated Berberine (UFBBN-10-23) supplementation in healthy volunteers. - Nil

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058210

Enrollment

Registered

2023-10-03

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: FBBN-10-23 500mg: 500mg Capsule, Single day Single dose oral administration of FBBN-10-23 Intervention2: FBBN-10-23 1000mg: 1000mg Capsule, Single day, Single dose oral administration o

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactJestin V Thomas

Leads Clinical Research and Bio Services Pvt. Ltd

jestin.leadsclinbio@gmail.com9845125293

Outcome results