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
This trial accepts healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Berberine incorporated in gamma cyclodextrin
Combination productExperimental modified product. One capsule contains 250 mg of Berberine from Indian Barberry (Berberis aristate DC.) Bark and Root Extract incorporated in gamma-cyclodextrin
Berberine
Dietary supplementActive comparator. One capsule contains 500 mg of Berberine from Indian Barberry (Berberis aristate DC.) Bark and Root Extract
Treatment groups
16 Participants
are divided into 2 treatment groupsGroup A: Berberine MetX™ Ultra AbsorptionExperimental treatment 1 intervention
Group B: Berberine MetX™Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
The area under the plasma concentration versus time curve (AUC, expressed in ng x h/mL) of berberine incorporated in gamma-cyclodextrin
The changes from the baseline the concentration (ng/ml) of berberine in blood plasma obtained after oral administration of the experimental product BBA.
Time frame
0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72 and 96 hours, post-dose2
The area under the plasma concentration versus time curve (AUC, expressed in ng x h/mL) of berberine
The changes from the baseline the concentration (ng/ml) of berberine in blood plasma obtained after oral administration of the active comparator BB.
Time frame
0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72 and 96 hours, post-doseSecondary outcomes
1
The absorption rate constants (Ka, h-1) of berberine incorporated in gamma-cyclodextrin
The absorption rate constants (Ka, h-1) of berberine obtained after oral administration of the experimental modified product BBA.
Time frame
0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72 and 96 hours, post-dose2
The absorption rate constants (Ka, h-1) of berberine
The absorption rate constants (Ka, h-1) of berberine obtained after oral administration of the active comparator BB.
Time frame
0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72 and 96 hours, post-dose3
Maximum plasma concentration (Cmax, ng/ml) of Berberine incorporated in gamma-cyclodextrin
Maximum plasma concentration (Cmax, ng/ml), of berberine obtained after oral administration of the experimental modified product BBA
Time frame
0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72, and 96 hours, post-dose4
Maximum plasma concentration (Cmax, ng/ml) of Berberine
Maximum plasma concentration (Cmax, ng/ml), of berberine - obtained after oral administration of the active comparator BB.
Time frame
0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72, and 96 hours, post-doseOther outcomes
1
Relative bioavailability (%) of berberine incorporated in gamma-cyclodextrin
Relative bioavailability (%) of Berberine from 0 to 96 hours defined as the ratio of AUC0-96h for the tested formulation (Berberine MetX™ Ultra Absorption capsules) to the AUC0-96h obtained for the reference product (100%, Berberine MetX™ Ultra capsules), given by the same route of administration in the same dose. F= AUCBBA/AUCBB x 100%
Time frame
0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72, and 96 hours, post-dose2
Effect of gamma-cyclodextrin on absorption rate constant (Ka, h-1) of berberine
The difference in the absorption rate constants (Ka, h-1) of berberine obtained after oral administration of BBA, and BB.
Time frame
0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72, and 96 hours, post-dose3
Effect of gamma-cyclodextrin on the maximal concentration (ng/ml) of berberine in blood
The difference in Cmax (ng/ml) of berberine obtained after oral administration of BBA and BB.
Time frame
0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72, and 96 hours, post-dose4
Effect of gamma-cyclodextrin on time (h) to reach maximum plasma concentration of berberine
The difference in Tmax (h) of berberine obtained after oral administration of BBA, and BB.
Time frame
0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72, and 96 hours, post-doseSponsors and contacts
Click on the lead sponsor to view all of their trials.
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
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