Drug AbsorptionPhase 1NCT04918667
Effect of Gamma-cyclodextrin on the Bioavailability of Berberine
A Phase 1 study testing Berberine incorporated in gamma cyclodextrin and Berberine in people with Drug Absorption, run by EuroPharma, Inc. at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Absorption
- What is being tested?
- Berberine incorporated in gamma cyclodextrin and Berberine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Sep 2024to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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),
Show all 15Show fewer
- 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).
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Jennifer Hansgate contact
4 sites in 2 countries
Armenia3 sites
CARDIOMED Family Health Center, LLC of the Ministry of Health of the Republic of Armenia
Yerevan
Samvel Hairumyan, PhD, MD, +37493203057, hsamvel@mail.ru
Institute of Fine Organic Chemistry of the National Academy of Science
Yerevan
Areg Hovhannisyan, PhD Areg Hovhannisyan, PhD, PhD, +37494282018, areglab@mail.ru
Scientific Center of Drug and Medical Technologies Expertise
Yerevan
Aghavni Ginosyan, PhD, MD, +37493360653, aghavni_ginosian@yahoo.com
Sweden1 site
Phytomed AB
Våxtorp, HL, 31275
Alexander G., +46733306226, ap@phytomed.se
About this study
Official title: A Phase I, Randomized, Crossover, Double-blind, Pharmacokinetic Study of Berberine Released From Cyclodextrin in Healthy Volunteers
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:
- Capsules containing Berberine and GCD (BBA Berberine MetX™ Ultra Absorption, 250 mg) B. Capsules containing Berberine (BB, Berberine MetX™, 500 mg) - (reference product).
Read the 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:
- 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
- Drug Absorption
- Being tested
- Berberine incorporated in gamma cyclodextrin, Berberine
- Keywords
- Berberine, gamma-cyclodextrin, Pharmacokinetic, Bioavailability, Berberine MetX™ Ultra Absorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Berberine incorporated in gamma cyclodextrinCombination product
Also called Berberine MetX™ Ultra Absorption, 250 mg
Experimental modified product. One capsule contains 250 mg of Berberine from Indian Barberry (Berberis aristate DC.) Bark and Root Extract incorporated in gamma-cyclodextrin
BerberineDietary supplement
Also called Berberine MetX™, 500 mg
Active comparator. One capsule contains 500 mg of Berberine from Indian Barberry (Berberis aristate DC.) Bark and Root Extract
| Study group | Role | What they receive |
|---|---|---|
| Berberine MetX™ Ultra Absorption | Experimental | 16 healthy subjects will receive orally 500 mg of berberine in two capsules of Berberine MetX™ Ultra Absorption. Receives: Combination Product: Berberine incorporated in gamma cyclodextrin |
| Berberine MetX™ | Active comparator | 16 healthy subjects will receive orally 500 mg of berberine in one capsule of Berberine MetX™ (reference product). Receives: Dietary Supplement: Berberine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72 and 96 hours, post-dose
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.
Measured: 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72 and 96 hours, post-dose
Secondary outcomes (8)
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.
Measured: 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72 and 96 hours, post-dose
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.
Measured: 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72 and 96 hours, post-dose
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
Measured: 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72, and 96 hours, post-dose
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.
Measured: 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72, and 96 hours, post-dose
Time to reach maximum plasma concentration, Tmax (h) of berberine incorporated in gamma-cyclodextrin
Time to reach maximum plasma concentration, Tmax (h) of berberine obtained after oral administration of the experimental modified product BBA
Measured: 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72, and 96 hours, post-dose
Time to reach maximum plasma concentration, Tmax (h) of berberine
Time to reach maximum plasma concentration, Tmax (h) of berberine obtained after oral administration of the active comparator BB.
Measured: 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72, and 96 hours, post-dose
Mean absorption time MAT (h) of berberine incorporated in gamma-cyclodextrin
Mean absorption time MAT (h) of berberine obtained after oral administration of the experimental modified product BBA
Measured: 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72, and 96 hours, post-dose
Mean absorption time MAT (h) of berberine
Mean absorption time MAT (h) of berberine obtained after oral administration of the active comparator BB
Measured: 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72, and 96 hours, post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study startSep 2024 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Drug AbsorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EuroPharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Scientific Center of Drug and Medical Technologies Expertise of the Ministry of Health, Armenia, Cardiomed LLC, Armenia, Institute of Fine Organic Chemistry of the National Academy of Science, Armenia, Phytomed AB, Sweden
- Responsible party
- Sponsor
- Investigators
- Aghavni Ginosyan, PhD, MD, Principal investigator, Scientific Center of Drug and Medical Technologies Expertise of the Ministry of Health, ArmeniaSamvel Hairumyan, PhD, MD, Principal investigator, CARDIOMED Family Health Center, LLC of the Ministry of Health of the Republic of ArmeniaAreg Hovhannisyan, PhD, Principal investigator, Institute of Fine Organic Chemistry of the National Academy of Science, ArmeniaAlexander G Panossian, PhD, Study director, Phytomed AB, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918667
- Sponsor's protocol ID
- EP-1007
- Status last verified
- Sep 2023
- First submitted
- 1 Jun 2021
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26851175Xu 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.
PubMed 33186794Loftsson 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.
PubMed 26059798Kamigauchi 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.
PubMed 17473458Hopwood 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.
PubMed 7765426Tannous 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.
PubMed 33113141Uekama 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.
PubMed 15304981
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Crossover, Double-blind, Pharmacokinetic Study of Berberine Released From Cyclodextrin in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04918667
- Acronym / sponsor ID
- EP-1007
- Conditions
- Drug Absorption
- Keywords
- Berberine, gamma-cyclodextrin, Pharmacokinetic, Bioavailability, Berberine MetX™ Ultra Absorption
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- EuroPharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Scientific Center of Drug and Medical Technologies Expertise of the Ministry of Health, Armenia, Cardiomed LLC, Armenia, Institute of Fine Organic Chemistry of the National Academy of Science, Armenia, Phytomed AB, Sweden
- Study start
- Sep 2024 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Capsules containing Berberine and GCD (BBA Berberine MetX™ Ultra Absorption, 250 mg) B. Capsules containing Berberine (BB, Berberine MetX™, 500 mg) - (reference product).
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Berberine MetX™ Ultra Absorption | Experimental | Combination Product: Berberine incorporated in gamma cyclodextrin16 healthy subjects will receive orally 500 mg of berberine in two capsules of Berberine MetX™ Ultra Absorption. |
| Berberine MetX™ | Active comparator | Dietary Supplement: Berberine16 healthy subjects will receive orally 500 mg of berberine in one capsule of Berberine MetX™ (reference product). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- overweight (BMI >35 kg/m2),
- pregnancy,
- lactation,
- drug abuse,
- use of dietary supplements or any form of medication (with the exception of oral contraceptives),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Berberine incorporated in gamma cyclodextrinAlso: Berberine MetX™ Ultra Absorption, 250 mgExperimental modified product. One capsule contains 250 mg of Berberine from Indian Barberry (Berberis aristate DC.) Bark and Root Extract incorporated in gamma-cyclodextrin | Combination product | Berberine MetX™ Ultra Absorption |
| BerberineAlso: Berberine MetX™, 500 mgActive comparator. One capsule contains 500 mg of Berberine from Indian Barberry (Berberis aristate DC.) Bark and Root Extract | Dietary supplement | Berberine MetX™ |
Primary outcome
The area under the plasma concentration versus time curve (AUC, expressed in ng x h/mL) of berberine incorporated in gamma-cyclodextrin
Time frame: 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72 and 96 hours, post-dose
The changes from the baseline the concentration (ng/ml) of berberine in blood plasma obtained after oral administration of the experimental product BBA.
The area under the plasma concentration versus time curve (AUC, expressed in ng x h/mL) of berberine
Time frame: 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72 and 96 hours, post-dose
The changes from the baseline the concentration (ng/ml) of berberine in blood plasma obtained after oral administration of the active comparator BB.
8 secondary outcomes
The absorption rate constants (Ka, h-1) of berberine incorporated in gamma-cyclodextrin
Time frame: 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72 and 96 hours, post-dose
The absorption rate constants (Ka, h-1) of berberine
Time frame: 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72 and 96 hours, post-dose
Maximum plasma concentration (Cmax, ng/ml) of Berberine incorporated in gamma-cyclodextrin
Time frame: 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72, and 96 hours, post-dose
Maximum plasma concentration (Cmax, ng/ml) of Berberine
Time frame: 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72, and 96 hours, post-dose
Time to reach maximum plasma concentration, Tmax (h) of berberine incorporated in gamma-cyclodextrin
Time frame: 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72, and 96 hours, post-dose
Time to reach maximum plasma concentration, Tmax (h) of berberine
Time frame: 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72, and 96 hours, post-dose
Mean absorption time MAT (h) of berberine incorporated in gamma-cyclodextrin
Time frame: 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72, and 96 hours, post-dose
Mean absorption time MAT (h) of berberine
Time frame: 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72, and 96 hours, post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Background: PubMed 26851175Liu 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.
- Background: PubMed 33186794Xu 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.
- Background: PubMed 26059798Loftsson 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.
- Background: PubMed 17473458Kamigauchi 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.
- Background: PubMed 7765426Hopwood 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.
- Background: PubMed 33113141Tannous 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.
- Background: PubMed 15304981Uekama 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Hansgate contact
Aghavni Ginosyan, PhD, MD principal investigator
Scientific Center of Drug and Medical Technologies Expertise of the Ministry of Health, Armenia
Samvel Hairumyan, PhD, MD principal investigator
CARDIOMED Family Health Center, LLC of the Ministry of Health of the Republic of Armenia
Areg Hovhannisyan, PhD principal investigator
Institute of Fine Organic Chemistry of the National Academy of Science, Armenia
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Berberine incorporated in gamma cyclodextrin and Berberine in people with Drug Absorption, run by EuroPharma, Inc. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Armenia, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander G. Panossian, PhD (+46733306226, ap@phytomed.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The area under the plasma concentration versus time curve (AUC, expressed in ng x h/mL) of berberine incorporated in gamma-cyclodextrin (time frame: 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72 and 96 hours, post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04918667, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.