Effect of Gamma-cyclodextrin on the Bioavailability of Berberine
ConditionDrug Absorption
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorEuroPharma, Inc.
About this trial
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 subjects after oral administration of:
A. Capsules containing Berberine and GCD (BBA Berberine MetX™ Ultra Absorption, 250 mg) B. Capsules containing Berberine (BB, Berberine MetX™, 500 mg) - (reference product).
Eligibility criteria
Qualifiers
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.
Disqualifiers
overweight (BMI >35 kg/m2),
pregnancy,
lactation,
drug abuse,
Trial design
Treatments tested in this trial
- Berberine incorporated in gamma cyclodextrin
- Berberine
Treatment groups
16 Participants
are divided into 2 treatment groupsSponsors and collaborators
EuroPharma, Inc.
Lead sponsor
Scientific Center of Drug and Medical Technologies Expertise of the Ministry of Health, Armenia
Collaborator
Cardiomed LLC, Armenia
Collaborator
Institute of Fine Organic Chemistry of the National Academy of Science, Armenia
Collaborator
Phytomed AB, Sweden
Collaborator
Source ClinicalTrials.gov