Drug AbsorptionPhase 1NCT04932265
Effect of Gamma-cyclodextrin on the Bioavailability of Ginsenosides
A Phase 1 study testing HRG80™ Red Ginseng and HRG80™ Red Ginseng + gamma cyclodextrin in people with Drug Absorption, run by EuroPharma, Inc. at 4 sites in 2 countries.
Trial summary
This study will evaluate the relative bioavailability of ginsenosides Rg5, Rk1, and Ck of Red ginseng HRG80 preparations containing gamma-cyclodextrin (GCD) in the blood plasma of healthy subjects after oral administration of two different formulations of HRG80: 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?
- HRG80™ Red Ginseng and HRG80™ Red Ginseng + gamma cyclodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Sep 2021to 26 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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, the gastrointestinal tract, endocrine organs, or other conditions such as the metabolic disease is 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.
4 sites in 2 countries
Armenia3 sites
CARDIOMED Family Health Center, LLC of the Ministry of Health of the Republic of Armenia
Yerevan
Institute of Fine Organic Chemistry of the National Academy of Science
Yerevan
Scientific Center of Drug and Medical Technologies Expertise
Yerevan
About this study
Official title: Dissolution and Pharmacokinetic of Ginsenosides Released From Cyclodextrin Based Chewable Tablets: a Comparative, Randomized, Crossover, Open-label Study in Healthy Human Subjects.
This study will evaluate the relative bioavailability of ginsenosides Rg5, Rk1, and Ck of Red ginseng HRG80 preparations containing gamma-cyclodextrin (GCD) in the blood plasma of healthy subjects after oral administration of two different formulations of HRG80:
- Capsules containing red ginseng preparation HRG80 (reference product) B. Chewable tablets containing red ginseng preparation HRG80 and GCD (modified product).
Dissolution testing measures the rate and extend water solubility of ginsenosides from the reference (A) and the modified (B) products. The difference of in vitro dissolution profiles between the reference (A) and modified (B) products will be assessed.
Read the detailed description
A growing body of evidence suggests that gamma-cyclodextrin (GCD) can increase the clinical efficacy of water-insoluble biologically active compounds, which have low bioavailability. GCD is the most bio adaptable and applicable to increase the absorption of many drugs, including ginsenosides of Panax ginseng, by forming inclusion complexes or the form of GCD/drug conjugates. Ginsenosides have absolute bioavailability in the range from 0.2% to 48%, depending on the chemical structure and water solubility.
Hypothesis: gamma-cyclodextrin increases absorption and bioavailability of active constituents - Ginsenosides Rg5, Rk1, and Compound K (CK). The study aims to provide experimental evidence supporting or rejecting this hypothesis.
Sixteen healthy volunteers will be randomly assigned to receive two formulations, A and B, in two consecutive phases (Phase 1 and Phase) of an open-label study with a crossover design.
All patients will provide blood samples in each phase in each phase in 0.5, 0.75, 1, 2, 4, 6, 12, 24, and 48 hours (9 points) after drug administration, following will be a washout period for two weeks.
Subjects will be fasting for 10.00 hours before administering the investigational product. They will remain in the clinic post-dose until at least 24.00 hours each period, provided they are not suffering from any adverse event.
The concentration of ginsenosides Rg5, Rk1, and Ck in all blood samples will be determined using a validated 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
- HRG80™ Red Ginseng, HRG80™ Red Ginseng + gamma cyclodextrin
- Keywords
- Ginsenosides Rg5, Ginsenosides Rk1, Compound K (CK)., Red ginseng HRG80, gamma-cyclodextrin, pharmacokinetic, relative bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRG80™ Red GinsengDietary supplement
Also called HRG80™ Red Ginseng Energy
Capsules containing red ginseng preparation HRG80 capsules, 200 mg - reference product
HRG80™ Red Ginseng + gamma cyclodextrinCombination product
Also called HRG80™ Red Ginseng Energy Chewable
Chewable tablets containing red ginseng preparation HRG80 (100 mg) incorporated in gamma-cyclodextrin (GCD) - experimental modified product
| Study group | Role | What they receive |
|---|---|---|
| Red ginseng HRG80 | Active comparator | 16 subjects will receive 200 mg of red ginseng preparation HRG80 in one capsule Receives: Dietary Supplement: HRG80™ Red Ginseng |
| Red ginseng HRG80 incorporated in gamma-cyclodextrin | Experimental | 16 subjects will receive 200 mg of red ginseng preparation HRG80 incorporated in gamma-cyclodextrin in two chewable tablets Receives: Combination Product: HRG80™ Red Ginseng + gamma cyclodextrin |
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 Rg5.
The changes from the baseline the concentration (ng/ml) of Rg5 in blood plasma obtained after oral administration of the experimental product A or the active comparator B.
Measured: 0.5, 0.75, 1, 2, 4, 6, 12 and 24 hours, post-dose
The area under the plasma concentration versus time curve (AUC, expressed in ng x h/mL) of Rk1.
The changes from the baseline the concentration (ng/ml) of Rk1 in blood plasma obtained after oral administration of the experimental product A or the active comparator B.
Measured: 0.5, 0.75, 1, 2, 4, 6, 12 and 24 hours, post-dose
The area under the plasma concentration versus time curve (AUC, expressed in ng x h/mL) of ginsenoside Ck
The changes from the baseline the concentration (ng/ml) of ginsenoside Ck in blood plasma obtained after oral administration of the experimental product A or the active comparator B.
Measured: 0.5, 0.75, 1, 2, 4, 6, 12 and 24 hours, post-dose
Secondary outcomes (12)
The absorption rate constant (Ka, h-1) of Rg5
The absorption rate constants (Ka, h-1) of Rg5 in blood plasma obtained after oral administration of the experimental product A or the active comparator B.
Measured: 0.5, 0.75, 1, 2, 4, 6, 12 and 24 hours, post-dose
The absorption rate constant (Ka, h-1) of Rk1
The absorption rate constants (Ka, h-1) of Rk1 in blood plasma obtained after oral administration of the experimental product A or the active comparator B.
Measured: 0.5, 0.75, 1, 2, 4, 6, 12 and 24 hours, post-dose
The absorption rate constant (Ka, h-1) of Ck
The absorption rate constants (Ka, h-1) of Ck in blood plasma obtained after oral administration of the experimental product A or the active comparator B.
Measured: 0.5, 0.75, 1, 2, 4, 6, 12 and 24 hours, post-dose
Maximum plasma concentration (Cmax, ng/ml), of Rg5
Maximum plasma concentration (Cmax, ng/ml), of Rg5 in blood plasma obtained after oral administration of the experimental product A or the active comparator B.
Measured: 0.5, 0.75, 1, 2, 4, 6, 12 and 24 hours, post-dose
Maximum plasma concentration (Cmax, ng/ml), of Rk1
Maximum plasma concentration (Cmax, ng/ml), of Rk1 in blood plasma obtained after oral administration of the experimental product A or the active comparator B.
Measured: 0.5, 0.75, 1, 2, 4, 6, 12 and 24 hours, post-dose
Maximum plasma concentration (Cmax, ng/ml), of Ck
Maximum plasma concentration (Cmax, ng/ml), of Ck in blood plasma obtained after oral administration of the experimental product A or the active comparator B.
Measured: 0.5, 0.75, 1, 2, 4, 6, 12 and 24 hours, post-dose
Time to reach maximum plasma concentration, Tmax (h) of Rg5 .
Time to reach maximum plasma concentration, Tmax (h) of Rg5 in blood plasma obtained after oral administration of the experimental product A or the active comparator B.
Measured: 0.5, 0.75, 1, 2, 4, 6, 12 and 24 hours, post-dose
Time to reach maximum plasma concentration, Tmax (h) of Rk1
Time to reach maximum plasma concentration, Tmax (h) of Rk1 in blood plasma obtained after oral administration of the experimental product A or the active comparator B.
Measured: 0.5, 0.75, 1, 2, 4, 6, 12 and 24 hours, post-dose
Time to reach maximum plasma concentration, Tmax (h) of Ck.
Time to reach maximum plasma concentration, Tmax (h) of Ck in blood plasma obtained after oral administration of the experimental product A or the active comparator B.
Measured: 0.5, 0.75, 1, 2, 4, 6, 12 and 24 hours, post-dose
Mean absorption time MAT (h) of Rg5
Mean absorption time MAT (h) of Rg5 in blood plasma obtained after oral administration of the experimental product A or the active comparator B.
Measured: 0.5, 0.75, 1, 2, 4, 6, 12 and 24 hours, post-dose
Mean absorption time MAT (h) of Rk1
Mean absorption time MAT (h) of Rk1 in blood plasma obtained after oral administration of the experimental product A or the active comparator B.
Measured: 0.5, 0.75, 1, 2, 4, 6, 12 and 24 hours, post-dose
Mean absorption time MAT (h) of Ck
Mean absorption time MAT (h) of Ck in blood plasma obtained after oral administration of the experimental product A or the active comparator B.
Measured: 0.5, 0.75, 1, 2, 4, 6, 12 and 24 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 posted21 Jun 2021
- Study start1 Sep 2021
- Primary completion20 Dec 2024 (estimated)
- Study completion26 Dec 2025 (estimated)
Why it stopped: Technical Problems with sensitivity of mass spectral detector
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- Model description
- A comparative study with the positive control, parallel groups, randomized, crossover design
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- EuroPharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Phytomed AB, Sweden, Scientific Center of Drug and Medical Technologies Expertise of the Ministry of Health, Armenia, CARDIOMED Family Health Center, LLC of the Ministry of Health of Armenia, Institute of Fine Organic Chemistry of the National Academy of Science Yerevan, Armenia
- Responsible party
- Sponsor
- Investigators
- Aghavni T Ginosyan, PhD, MD, Principal investigator, Scientific Center of Drug and Medical Technologies Expertise of the Ministry of Health of the Republic of ArmeniaSamvel Hairumyan, PhD, MD, Principal investigator, CARDIOMED Family Health Center, LLC of the Ministry of Health of the Republic of ArmeniaAreg Hovhannisyan PhD of A Hovhannisyan, Study director, Institute of Fine Organic Chemistry of the National Academy of Science, Armenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932265
- Sponsor's protocol ID
- EP-1008
- 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
Publications
Yoo S, Park BI, Kim DH, Lee S, Lee SH, Shim WS, Seo YK, Kang K, Lee KT, Yim SV, Soung DY, Kim BH. Ginsenoside Absorption Rate and Extent Enhancement of Black Ginseng (CJ EnerG) over Red Ginseng in Healthy Adults. Pharmaceutics. 2021 Apr 2;13(4):487. doi: 10.3390/pharmaceutics13040487.
PubMed 33918329Zhou QL, Zhu DN, Yang YF, Xu W, Yang XW. Simultaneous quantification of twenty-one ginsenosides and their three aglycones in rat plasma by a developed UFLC-MS/MS assay: Application to a pharmacokinetic study of red ginseng. J Pharm Biomed Anal. 2017 Apr 15;137:1-12. doi: 10.1016/j.jpba.2017.01.009. Epub 2017 Jan 6.
PubMed 28086165Elshafay A, Tinh NX, Salman S, Shaheen YS, Othman EB, Elhady MT, Kansakar AR, Tran L, Van L, Hirayama K, Huy NT. Ginsenoside Rk1 bioactivity: a systematic review. PeerJ. 2017 Nov 17;5:e3993. doi: 10.7717/peerj.3993. eCollection 2017.
PubMed 29158964Kim HK. Pharmacokinetics of ginsenoside Rb1 and its metabolite compound K after oral administration of Korean Red Ginseng extract. J Ginseng Res. 2013 Oct;37(4):451-6. doi: 10.5142/jgr.2013.37.451.
PubMed 24235859Pan W, Xue B, Yang C, Miao L, Zhou L, Chen Q, Cai Q, Liu Y, Liu D, He H, Zhang Y, Yin T, Tang X. Biopharmaceutical characters and bioavailability improving strategies of ginsenosides. Fitoterapia. 2018 Sep;129:272-282. doi: 10.1016/j.fitote.2018.06.001. Epub 2018 Jun 5.
PubMed 29883635Quan LH, Jin Y, Wang C, Min JW, Kim YJ, Yang DC. Enzymatic transformation of the major ginsenoside Rb2 to minor compound Y and compound K by a ginsenoside-hydrolyzing beta-glycosidase from Microbacterium esteraromaticum. J Ind Microbiol Biotechnol. 2012 Oct;39(10):1557-62. doi: 10.1007/s10295-012-1158-1. Epub 2012 Jun 21.
PubMed 22717707Tannous 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 33113141Rivero-Barbarroja G, Benito JM, Ortiz Mellet C, Garcia Fernandez JM. Cyclodextrin-Based Functional Glyconanomaterials. Nanomaterials (Basel). 2020 Dec 15;10(12):2517. doi: 10.3390/nano10122517.
PubMed 33333914Li Z, Wang M, Wang F, Gu Z, Du G, Wu J, Chen J. gamma-Cyclodextrin: a review on enzymatic production and applications. Appl Microbiol Biotechnol. 2007 Nov;77(2):245-55. doi: 10.1007/s00253-007-1166-7. Epub 2007 Sep 22.
PubMed 17891389
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
- Dissolution and Pharmacokinetic of Ginsenosides Released From Cyclodextrin Based Chewable Tablets: a Comparative, Randomized, Crossover, Open-label Study in Healthy Human Subjects.
- ClinicalTrials.gov ID
- NCT04932265
- Acronym / sponsor ID
- EP-1008
- Conditions
- Drug Absorption
- Keywords
- Ginsenosides Rg5, Ginsenosides Rk1, Compound K (CK)., Red ginseng HRG80, gamma-cyclodextrin, pharmacokinetic, relative bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Technical Problems with sensitivity of mass spectral detector
- Enrolment
- 3 participants (actual)
- Lead sponsor
- EuroPharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Phytomed AB, Sweden, Scientific Center of Drug and Medical Technologies Expertise of the Ministry of Health, Armenia, CARDIOMED Family Health Center, LLC of the Ministry of Health of Armenia, Institute of Fine Organic Chemistry of the National Academy of Science Yerevan, Armenia
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 26 Dec 2025 (estimated)
- First posted
- 21 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.
This study will evaluate the relative bioavailability of ginsenosides Rg5, Rk1, and Ck of Red ginseng HRG80 preparations containing gamma-cyclodextrin (GCD) in the blood plasma of healthy subjects after oral administration of two different formulations of HRG80:
- Capsules containing red ginseng preparation HRG80 (reference product) B. Chewable tablets containing red ginseng preparation HRG80 and GCD (modified product).
Dissolution testing measures the rate and extend water solubility of ginsenosides from the reference (A) and the modified (B) products. The difference of in vitro dissolution profiles between the reference (A) and modified (B) products will be assessed.
Detailed description
A growing body of evidence suggests that gamma-cyclodextrin (GCD) can increase the clinical efficacy of water-insoluble biologically active compounds, which have low bioavailability. GCD is the most bio adaptable and applicable to increase the absorption of many drugs, including ginsenosides of Panax ginseng, by forming inclusion complexes or the form of GCD/drug conjugates. Ginsenosides have absolute bioavailability in the range from 0.2% to 48%, depending on the chemical structure and water solubility.
Hypothesis: gamma-cyclodextrin increases absorption and bioavailability of active constituents - Ginsenosides Rg5, Rk1, and Compound K (CK). The study aims to provide experimental evidence supporting or rejecting this hypothesis.
Sixteen healthy volunteers will be randomly assigned to receive two formulations, A and B, in two consecutive phases (Phase 1 and Phase) of an open-label study with a crossover design.
All patients will provide blood samples in each phase in each phase in 0.5, 0.75, 1, 2, 4, 6, 12, 24, and 48 hours (9 points) after drug administration, following will be a washout period for two weeks.
Subjects will be fasting for 10.00 hours before administering the investigational product. They will remain in the clinic post-dose until at least 24.00 hours each period, provided they are not suffering from any adverse event.
The concentration of ginsenosides Rg5, Rk1, and Ck in all blood samples will be determined using a validated 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
- None (open label)
- Number of arms
- 2
- Model description
- A comparative study with the positive control, parallel groups, randomized, crossover design
| Arm | Type | Receives |
|---|---|---|
| Red ginseng HRG80 | Active comparator | Dietary Supplement: HRG80™ Red Ginseng16 subjects will receive 200 mg of red ginseng preparation HRG80 in one capsule |
| Red ginseng HRG80 incorporated in gamma-cyclodextrin | Experimental | Combination Product: HRG80™ Red Ginseng + gamma cyclodextrin16 subjects will receive 200 mg of red ginseng preparation HRG80 incorporated in gamma-cyclodextrin in two chewable tablets |
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 |
|---|---|---|
| HRG80™ Red GinsengAlso: HRG80™ Red Ginseng EnergyCapsules containing red ginseng preparation HRG80 capsules, 200 mg - reference product | Dietary supplement | Red ginseng HRG80 |
| HRG80™ Red Ginseng + gamma cyclodextrinAlso: HRG80™ Red Ginseng Energy ChewableChewable tablets containing red ginseng preparation HRG80 (100 mg) incorporated in gamma-cyclodextrin (GCD) - experimental modified product | Combination product | Red ginseng HRG80 incorporated in gamma-cyclodextrin |
Primary outcome
The area under the plasma concentration versus time curve (AUC, expressed in ng x h/mL) of Rg5.
Time frame: 0.5, 0.75, 1, 2, 4, 6, 12 and 24 hours, post-dose
The changes from the baseline the concentration (ng/ml) of Rg5 in blood plasma obtained after oral administration of the experimental product A or the active comparator B.
The area under the plasma concentration versus time curve (AUC, expressed in ng x h/mL) of Rk1.
Time frame: 0.5, 0.75, 1, 2, 4, 6, 12 and 24 hours, post-dose
The changes from the baseline the concentration (ng/ml) of Rk1 in blood plasma obtained after oral administration of the experimental product A or the active comparator B.
The area under the plasma concentration versus time curve (AUC, expressed in ng x h/mL) of ginsenoside Ck
Time frame: 0.5, 0.75, 1, 2, 4, 6, 12 and 24 hours, post-dose
The changes from the baseline the concentration (ng/ml) of ginsenoside Ck in blood plasma obtained after oral administration of the experimental product A or the active comparator B.
12 secondary outcomes
The absorption rate constant (Ka, h-1) of Rg5
Time frame: 0.5, 0.75, 1, 2, 4, 6, 12 and 24 hours, post-dose
The absorption rate constant (Ka, h-1) of Rk1
Time frame: 0.5, 0.75, 1, 2, 4, 6, 12 and 24 hours, post-dose
The absorption rate constant (Ka, h-1) of Ck
Time frame: 0.5, 0.75, 1, 2, 4, 6, 12 and 24 hours, post-dose
Maximum plasma concentration (Cmax, ng/ml), of Rg5
Time frame: 0.5, 0.75, 1, 2, 4, 6, 12 and 24 hours, post-dose
Maximum plasma concentration (Cmax, ng/ml), of Rk1
Time frame: 0.5, 0.75, 1, 2, 4, 6, 12 and 24 hours, post-dose
Maximum plasma concentration (Cmax, ng/ml), of Ck
Time frame: 0.5, 0.75, 1, 2, 4, 6, 12 and 24 hours, post-dose
Time to reach maximum plasma concentration, Tmax (h) of Rg5 .
Time frame: 0.5, 0.75, 1, 2, 4, 6, 12 and 24 hours, post-dose
Time to reach maximum plasma concentration, Tmax (h) of Rk1
Time frame: 0.5, 0.75, 1, 2, 4, 6, 12 and 24 hours, post-dose
Time to reach maximum plasma concentration, Tmax (h) of Ck.
Time frame: 0.5, 0.75, 1, 2, 4, 6, 12 and 24 hours, post-dose
Mean absorption time MAT (h) of Rg5
Time frame: 0.5, 0.75, 1, 2, 4, 6, 12 and 24 hours, post-dose
Mean absorption time MAT (h) of Rk1
Time frame: 0.5, 0.75, 1, 2, 4, 6, 12 and 24 hours, post-dose
Mean absorption time MAT (h) of Ck
Time frame: 0.5, 0.75, 1, 2, 4, 6, 12 and 24 hours, post-dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Background: PubMed 33918329Yoo S, Park BI, Kim DH, Lee S, Lee SH, Shim WS, Seo YK, Kang K, Lee KT, Yim SV, Soung DY, Kim BH. Ginsenoside Absorption Rate and Extent Enhancement of Black Ginseng (CJ EnerG) over Red Ginseng in Healthy Adults. Pharmaceutics. 2021 Apr 2;13(4):487. doi: 10.3390/pharmaceutics13040487.
- Background: PubMed 28086165Zhou QL, Zhu DN, Yang YF, Xu W, Yang XW. Simultaneous quantification of twenty-one ginsenosides and their three aglycones in rat plasma by a developed UFLC-MS/MS assay: Application to a pharmacokinetic study of red ginseng. J Pharm Biomed Anal. 2017 Apr 15;137:1-12. doi: 10.1016/j.jpba.2017.01.009. Epub 2017 Jan 6.
- Background: PubMed 29158964Elshafay A, Tinh NX, Salman S, Shaheen YS, Othman EB, Elhady MT, Kansakar AR, Tran L, Van L, Hirayama K, Huy NT. Ginsenoside Rk1 bioactivity: a systematic review. PeerJ. 2017 Nov 17;5:e3993. doi: 10.7717/peerj.3993. eCollection 2017.
- Background: PubMed 24235859Kim HK. Pharmacokinetics of ginsenoside Rb1 and its metabolite compound K after oral administration of Korean Red Ginseng extract. J Ginseng Res. 2013 Oct;37(4):451-6. doi: 10.5142/jgr.2013.37.451.
- Background: PubMed 29883635Pan W, Xue B, Yang C, Miao L, Zhou L, Chen Q, Cai Q, Liu Y, Liu D, He H, Zhang Y, Yin T, Tang X. Biopharmaceutical characters and bioavailability improving strategies of ginsenosides. Fitoterapia. 2018 Sep;129:272-282. doi: 10.1016/j.fitote.2018.06.001. Epub 2018 Jun 5.
- Background: PubMed 22717707Quan LH, Jin Y, Wang C, Min JW, Kim YJ, Yang DC. Enzymatic transformation of the major ginsenoside Rb2 to minor compound Y and compound K by a ginsenoside-hydrolyzing beta-glycosidase from Microbacterium esteraromaticum. J Ind Microbiol Biotechnol. 2012 Oct;39(10):1557-62. doi: 10.1007/s10295-012-1158-1. Epub 2012 Jun 21.
- 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 33333914Rivero-Barbarroja G, Benito JM, Ortiz Mellet C, Garcia Fernandez JM. Cyclodextrin-Based Functional Glyconanomaterials. Nanomaterials (Basel). 2020 Dec 15;10(12):2517. doi: 10.3390/nano10122517.
- Background: PubMed 17891389Li Z, Wang M, Wang F, Gu Z, Du G, Wu J, Chen J. gamma-Cyclodextrin: a review on enzymatic production and applications. Appl Microbiol Biotechnol. 2007 Nov;77(2):245-55. doi: 10.1007/s00253-007-1166-7. Epub 2007 Sep 22.
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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. This study is not recruiting at the moment.
Aghavni T Ginosyan, PhD, MD principal investigator
Scientific Center of Drug and Medical Technologies Expertise of the Ministry of Health of the Republic of 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 of A Hovhannisyan study director
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 HRG80™ Red Ginseng and HRG80™ Red Ginseng + gamma cyclodextrin 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: paused, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 Rg5. (time frame: 0.5, 0.75, 1, 2, 4, 6, 12 and 24 hours, post-dose). The study lists 3 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 NCT04932265, which also lists 9 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.