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G-PUR® for Reduced Lead Bioavailability

NCT04138693 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2020-06-04

No results posted yet for this study

Summary

This is a prospective, randomized, placebo-controlled, double blind, parallel-arm study in a two-staged approach that will assess the effect of two different doses of G-PUR® on enteral lead absorption in healthy adults using a stable lead isotopic tracer (204Pb).

Conditions

  • Lead Exposure

Interventions

DEVICE

G-PUR® 2x 2.0 g oral suspension

Cohort 1: 2 g G-PUR® powder mixed with 100 ml water in an opaque drinking bottle will be orally administered before and immediately after 204Pb intake

DEVICE

G-PUR® 1x 2.0 g oral suspension

Cohort 2: 2 g G-PUR® powder mixed with 100 ml water in an opaque drinking bottle will be orally administered before 204Pb intake and 100 ml water (placebo) in an opaque drinking bottle immediately after 204Pb intake

DEVICE

Placebo oral suspension

Cohort 3: 100 ml of water in an opaque drinking bottle will be orally administered immediately before and after 204Pb intake

Sponsors & Collaborators

  • Glock Health, Science and Research GmbH

    lead INDUSTRY

Principal Investigators

  • Christa Firbas, Dr. · Medical University Vienna, Department of Clinical Pharmacology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-09-24
Primary Completion
2020-02-12
Completion
2020-02-12

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 NCT04138693 on ClinicalTrials.gov