Effect of Gamma-cyclodextrin on the Bioavailability of Berberine
NCT ID: NCT04918667
Last Updated: 2023-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
16 participants
INTERVENTIONAL
2024-09-30
2026-12-31
Brief Summary
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A. Capsules containing Berberine and GCD (BBA Berberine MetX™ Ultra Absorption, 250 mg) B. Capsules containing Berberine (BB, Berberine MetX™, 500 mg) - (reference product).
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Detailed Description
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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 the most bio adaptable and helpful to increase the absorption of many drugs, including Berberine from Indian Barberry (Berberis aristate DC.) Bark and Root Extract by forming inclusion complexes or GCD/drug conjugates.
Berberine has been recommended in traditional practice and recognized by modern science to support healthy blood sugar†, cholesterol and triglyceride levels, and overall metabolic health. But despite these findings, standard Berberine can still be difficult for the body to absorb and use effectively.
It's estimated that only about five percent of any given dosage of Berberine makes it into the bloodstream, so finding a way to enhance absorption is key to the full advantage of its benefits.
Hypothesis: gamma-cyclodextrin increases absorption and bioavailability of Berberine from Berberine MetX™ Ultra Absorption capsules.
The study aims to provide experimental evidence supporting or rejecting this hypothesis.
This will be a double-blind, crossover design, pharmacokinetic study, where 16 healthy human volunteers will be randomly assigned to receive two different formulations BBA, and BB, in two consecutive phases of the study:
* Phase A. All patients take capsules BBA., provide blood samples in 0.5, 0.75, 1, 2, 4, 6, 12, 24, and 48 hours (9 points) after administration following washout period for two weeks.
* Phase B. All patients take capsules BB, provide blood samples in 0.5, 0.75, 1, 2, 4, 6, 12, 24, and 48 hours (9 points) after administration following washout period for two weeks.
Subjects will be in the clinic from not less than 11 hours pre-dose to ensure at least 10 hours fasting before administering the investigational product. They will remain in the facility post-dose until at least 24 hours each period, provided they are not suffering from any adverse event.
The concentration of Berberine in all blood samples will be determined using a validated for a limit of detection, accuracy, and precision analytical method (HPLC-MS) with the internal standard - digoxin. Appropriate mathematical methods and Kinetic 4.4.1 software will be used to generate basic pharmacokinetic parameters.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Berberine MetX™ Ultra Absorption
16 healthy subjects will receive orally 500 mg of berberine in two capsules of Berberine MetX™ Ultra Absorption.
Berberine incorporated in gamma cyclodextrin
Experimental modified product. One capsule contains 250 mg of Berberine from Indian Barberry (Berberis aristate DC.) Bark and Root Extract incorporated in gamma-cyclodextrin
Berberine MetX™
16 healthy subjects will receive orally 500 mg of berberine in one capsule of Berberine MetX™ (reference product).
Berberine
Active comparator. One capsule contains 500 mg of Berberine from Indian Barberry (Berberis aristate DC.) Bark and Root Extract
Interventions
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Berberine incorporated in gamma cyclodextrin
Experimental modified product. One capsule contains 250 mg of Berberine from Indian Barberry (Berberis aristate DC.) Bark and Root Extract incorporated in gamma-cyclodextrin
Berberine
Active comparator. One capsule contains 500 mg of Berberine from Indian Barberry (Berberis aristate DC.) Bark and Root Extract
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willingness to stay in the unit overnight for the duration of the study,
* Provide a signed written informed consent.
Exclusion Criteria
* 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).
18 Years
60 Years
ALL
Yes
Sponsors
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Scientific Center of Drug and Medical Technologies Expertise of the Ministry of Health, Armenia
UNKNOWN
Cardiomed LLC, Armenia
UNKNOWN
Institute of Fine Organic Chemistry of the National Academy of Science, Armenia
UNKNOWN
Phytomed AB, Sweden
UNKNOWN
EuroPharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Aghavni Ginosyan, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Scientific Center of Drug and Medical Technologies Expertise of the Ministry of Health, Armenia
Samvel Hairumyan, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
CARDIOMED Family Health Center, LLC of the Ministry of Health of the Republic of Armenia
Areg Hovhannisyan, PhD
Role: PRINCIPAL_INVESTIGATOR
Institute of Fine Organic Chemistry of the National Academy of Science, Armenia
Alexander G Panossian, PhD
Role: STUDY_DIRECTOR
Phytomed AB, Sweden
Locations
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CARDIOMED Family Health Center, LLC of the Ministry of Health of the Republic of Armenia
Yerevan, , Armenia
Institute of Fine Organic Chemistry of the National Academy of Science
Yerevan, , Armenia
Scientific Center of Drug and Medical Technologies Expertise
Yerevan, , Armenia
Phytomed AB
Våxtorp, HL, Sweden
Countries
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Central Contacts
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Facility Contacts
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References
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Liu CS, Zheng YR, Zhang YF, Long XY. Research progress on berberine with a special focus on its oral bioavailability. Fitoterapia. 2016 Mar;109:274-82. doi: 10.1016/j.fitote.2016.02.001. Epub 2016 Feb 2.
Xu X, Yi H, Wu J, Kuang T, Zhang J, Li Q, Du H, Xu T, Jiang G, Fan G. Therapeutic effect of berberine on metabolic diseases: Both pharmacological data and clinical evidence. Biomed Pharmacother. 2021 Jan;133:110984. doi: 10.1016/j.biopha.2020.110984. Epub 2020 Nov 10.
Loftsson T, Moya-Ortega MD, Alvarez-Lorenzo C, Concheiro A. Pharmacokinetics of cyclodextrins and drugs after oral and parenteral administration of drug/cyclodextrin complexes. J Pharm Pharmacol. 2016 May;68(5):544-55. doi: 10.1111/jphp.12427. Epub 2015 Jun 9.
Kamigauchi M, Kawanishi K, Ohishi H, Ishida T. Inclusion effect and structural basis of cyclodextrins for increased extraction of medicinal alkaloids from natural medicines. Chem Pharm Bull (Tokyo). 2007 May;55(5):729-33. doi: 10.1248/cpb.55.729.
Hopwood VL, Pathak S. Improved quality of Giemsa banding by the use of trypsin concentrate. Am Biotechnol Lab. 1994 Oct;12(11):52. No abstract available.
Tannous M, Caldera F, Hoti G, Dianzani U, Cavalli R, Trotta F. Drug-Encapsulated Cyclodextrin Nanosponges. Methods Mol Biol. 2021;2207:247-283. doi: 10.1007/978-1-0716-0920-0_19.
Uekama K. Design and evaluation of cyclodextrin-based drug formulation. Chem Pharm Bull (Tokyo). 2004 Aug;52(8):900-15. doi: 10.1248/cpb.52.900.
Other Identifiers
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EP-1007
Identifier Type: -
Identifier Source: org_study_id
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