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).
Condition or disease | Intervention/treatment | Phase |
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Drug Absorption | Combination Product: Berberine incorporated in gamma cyclodextrin Dietary Supplement: Berberine | Phase 1 |
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 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:
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 16 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase I, Randomized, Crossover, Double-blind, Pharmacokinetic Study of Berberine Released From Cyclodextrin in Healthy Volunteers |
Estimated Study Start Date : | September 2021 |
Estimated Primary Completion Date : | November 2021 |
Estimated Study Completion Date : | December 2022 |
Arm | Intervention/treatment |
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Experimental: Berberine MetX™ Ultra Absorption
16 healthy subjects will receive orally 500 mg of berberine in two capsules of Berberine MetX™ Ultra Absorption.
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Combination Product: 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
Other Name: Berberine MetX™ Ultra Absorption, 250 mg
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Active Comparator: Berberine MetX™
16 healthy subjects will receive orally 500 mg of berberine in one capsule of Berberine MetX™ (reference product).
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Dietary Supplement: Berberine
Active comparator. One capsule contains 500 mg of Berberine from Indian Barberry (Berberis aristate DC.) Bark and Root Extract
Other Name: Berberine MetX™, 500 mg
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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alexander G. Panossian, PhD | +46733306226 | ap@phytomed.se | |
Contact: Jennifer Hansgate | jhansgate@europharmausa.com |
Armenia | |
CARDIOMED Family Health Center, LLC of the Ministry of Health of the Republic of Armenia | |
Yerevan, Armenia | |
Contact: Samvel Hairumyan, PhD, MD +37493203057 hsamvel@mail.ru | |
Institute of Fine Organic Chemistry of the National Academy of Science | |
Yerevan, Armenia | |
Contact: Areg Hovhannisyan, PhD Areg Hovhannisyan, PhD, PhD +37494282018 areglab@mail.ru | |
Scientific Center of Drug and Medical Technologies Expertise | |
Yerevan, Armenia | |
Contact: Aghavni Ginosyan, PhD, MD +37493360653 aghavni_ginosian@yahoo.com | |
Sweden | |
Phytomed AB | |
Vaxtorp, HL, Sweden, 31275 | |
Contact: Alexander G. +46733306226 ap@phytomed.se |
Principal Investigator: | Aghavni Ginosyan, PhD, MD | Scientific Center of Drug and Medical Technologies Expertise of the Ministry of Health, Armenia | |
Principal Investigator: | Samvel Hairumyan, PhD, MD | CARDIOMED Family Health Center, LLC of the Ministry of Health of the Republic of Armenia | |
Principal Investigator: | Areg Hovhannisyan, PhD | Institute of Fine Organic Chemistry of the National Academy of Science, Armenia | |
Study Director: | Alexander G Panossian, PhD | Phytomed AB, Sweden |
Tracking Information | |||||||||||||
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First Submitted Date ICMJE | June 1, 2021 | ||||||||||||
First Posted Date ICMJE | June 9, 2021 | ||||||||||||
Last Update Posted Date | August 18, 2021 | ||||||||||||
Estimated Study Start Date ICMJE | September 2021 | ||||||||||||
Estimated Primary Completion Date | November 2021 (Final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
Change History | |||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||||||||||
Descriptive Information | |||||||||||||
Brief Title ICMJE | Effect of Gamma-cyclodextrin on the Bioavailability of Berberine | ||||||||||||
Official Title ICMJE | A Phase I, Randomized, Crossover, Double-blind, Pharmacokinetic Study of Berberine Released From Cyclodextrin in Healthy Volunteers | ||||||||||||
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 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). |
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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 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:
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. |
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Study Type ICMJE | Interventional | ||||||||||||
Study Phase ICMJE | Phase 1 | ||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Drug Absorption | ||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||||||
Estimated Enrollment ICMJE |
16 | ||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||
Estimated Study Completion Date ICMJE | December 2022 | ||||||||||||
Estimated Primary Completion Date | November 2021 (Final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 60 Years (Adult) | ||||||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Armenia, Sweden | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT04918667 | ||||||||||||
Other Study ID Numbers ICMJE | EP-1007 | ||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | EuroPharma, Inc. | ||||||||||||
Study Sponsor ICMJE | EuroPharma, Inc. | ||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | EuroPharma, Inc. | ||||||||||||
Verification Date | August 2021 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |