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Effect of Gamma-cyclodextrin on the Bioavailability of Ginsenosides

NCT04932265 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2023-09-14

No results posted yet for this study

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. 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.

Conditions

  • Drug Absorption

Interventions

DIETARY_SUPPLEMENT

HRG80™ Red Ginseng

Capsules containing red ginseng preparation HRG80 capsules, 200 mg - reference product

COMBINATION_PRODUCT

HRG80™ Red Ginseng + gamma cyclodextrin

Chewable tablets containing red ginseng preparation HRG80 (100 mg) incorporated in gamma-cyclodextrin (GCD) - experimental modified product

Sponsors & Collaborators

  • Phytomed AB, Sweden

    collaborator UNKNOWN

  • Scientific Center of Drug and Medical Technologies Expertise of the Ministry of Health, Armenia

    collaborator UNKNOWN

  • CARDIOMED Family Health Center, LLC of the Ministry of Health of Armenia

    collaborator UNKNOWN

  • Institute of Fine Organic Chemistry of the National Academy of Science Yerevan, Armenia

    collaborator UNKNOWN

  • EuroPharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Aghavni T Ginosyan, PhD, MD · Scientific Center of Drug and Medical Technologies Expertise of the Ministry of Health of the Republic of Armenia

  • Samvel Hairumyan, PhD, MD · CARDIOMED Family Health Center, LLC of the Ministry of Health of the Republic of Armenia

  • Areg Hovhannisyan PhD of A Hovhannisyan · Institute of Fine Organic Chemistry of the National Academy of Science, Armenia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2024-12-20
Completion
2025-12-26

Countries

  • Armenia
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04932265 on ClinicalTrials.gov