Status:
NOT_YET_RECRUITING
Effect of Gamma-cyclodextrin on the Bioavailability of Berberine
Lead Sponsor:
EuroPharma, Inc.
Collaborating Sponsors:
Scientific Center of Drug and Medical Technologies Expertise of the Ministry of Health, Armenia
Cardiomed LLC, Armenia
Conditions:
Drug Absorption
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
In this study, we will evaluate the relative bioavailability of Berberine (BB) from capsules containing Indian Barberry (Berberis aristate DC.) Bark and Root Extract in the blood plasma of healthy sub...
Detailed Description
Study Background A growing body of evidence suggests that gamma-cyclodextrin (GCD) can increase the clinical efficacy of water-insoluble biologically active compounds with low bioavailability. GCD is...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04918667
Start Date
September 1 2024
End Date
December 1 2026
Last Update
September 14 2023
Active Locations (4)
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1
CARDIOMED Family Health Center, LLC of the Ministry of Health of the Republic of Armenia
Yerevan, Armenia
2
Institute of Fine Organic Chemistry of the National Academy of Science
Yerevan, Armenia
3
Scientific Center of Drug and Medical Technologies Expertise
Yerevan, Armenia
4
Phytomed AB
Våxtorp, HL, Sweden, 31275