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G-PUR® for Reduced Dietary Fumonisin Bioavailability

NCT04494178 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2020-11-16

No results posted yet for this study

Summary

This prospective, placebo-controlled, randomized, monocentric, double-blind, crossover study in healthy volunteers aims to assess the effect of a single dose of 2 g G-PUR® on bioavailability of dietary fumonisin and to evaluate safety and tolerability.

Conditions

  • Reduction of Dietary Fumonisin Bioavailability

Interventions

DEVICE

2.0g G-PUR®

Oral administration (Intervention period I)

DEVICE

2.0g G-PUR®

Oral administration (Intervention period II)

OTHER

Placebo

Intervention period I

OTHER

Placebo

Intervention period II

Sponsors & Collaborators

  • Glock Health, Science and Research GmbH

    lead INDUSTRY

Principal Investigators

  • Michael Wolzt, Prof.Dr. · Department of Clinical Pharmacology, Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2020-08-18
Primary Completion
2020-11-04
Completion
2020-11-04

Countries

  • Austria

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 NCT04494178 on ClinicalTrials.gov