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Effect of Gamma-cyclodextrin on the Bioavailability of Berberine

NCT04918667 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-09-14

No results posted yet for this study

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).

Conditions

  • Drug Absorption

Interventions

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

DIETARY_SUPPLEMENT

Berberine

Active comparator. One capsule contains 500 mg of Berberine from Indian Barberry (Berberis aristate DC.) Bark and Root Extract

Sponsors & Collaborators

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

    collaborator UNKNOWN

  • Cardiomed LLC, Armenia

    collaborator UNKNOWN

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

    collaborator UNKNOWN

  • Phytomed AB, Sweden

    collaborator UNKNOWN

  • EuroPharma, Inc.

    lead INDUSTRY

Principal Investigators

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

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

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

  • Alexander G Panossian, PhD · Phytomed AB, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2025-11-30
Completion
2026-12-31

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 NCT04918667 on ClinicalTrials.gov