Effect of Gamma-cyclodextrin on the Bioavailability of Berberine

Launched by EUROPHARMA, INC. · Jun 7, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how well a substance called Berberine, which comes from the Indian Barberry plant, is absorbed into the bloodstream when taken in two different types of capsules. One type of capsule contains Berberine along with another ingredient called gamma-cyclodextrin, which may help the body absorb Berberine better. The researchers want to see if this combination improves how much Berberine gets into the blood compared to capsules that contain only Berberine.

To participate in this study, you need to be a healthy adult between the ages of 18 and 65. You will need to stay overnight at the study facility during the trial, and you must be willing to sign a form agreeing to take part. Certain people, like those who are pregnant, have specific health issues, or are taking certain medications, won't be eligible to join. If you qualify, you can expect to take the capsules and have your blood tested to see how well the Berberine is absorbed. This research could help improve how Berberine is used in the future, especially for those looking for natural health options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy volunteers, as determined by medical history, physical examination, and clinical laboratory testing,
• • Willingness to stay in the unit overnight for the duration of the study,
• • Provide a signed written informed consent.
• Exclusion Criteria:
• • overweight (BMI \>35 kg/m2),
• • pregnancy,
• • lactation,
• • drug abuse,
• • use of dietary supplements or any form of medication (with the exception of oral contraceptives),
• • heavy smokers, or ex-smokers with a remote history (\> one pack/day),
• • frequent alcohol consumption (\>20 g ethanol/d),
• • adherence to a restrictive dietary regimen,
• • physical activity of more than 5 h/wk,
• • respiratory tract infections, or suspicion thereof in the last 14 days before dosing,
• • history or presence of disease in the kidneys and heart, lungs, liver, gastrointestinal tract, endocrine organs or other conditions such as metabolic disease known to interfere with the absorption, distribution, metabolism, and excretion of drugs,
• • malignancy,
• • autoimmune disorders such as (but not limited to) lupus erythematosus, multiple sclerosis, rheumatoid arthritis, or sarcoidosis,
• • any other disease or condition, which, in the opinion of the Investigator, would make the subject unsuitable for this study,
• • currently taking medications known to be CYP2C9 inducers (i.e., carbamazepine and rifampicin).