Status:
TERMINATED
G-PUR® for Reduced Dietary Fumonisin Bioavailability
Lead Sponsor:
Glock Health, Science and Research GmbH
Conditions:
Reduction of Dietary Fumonisin Bioavailability
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief 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 dietar...
Eligibility Criteria
Inclusion
- Healthy male and female subjects
- Age 18-55 years
- BMI 17-27
- Subjects are in good clinical and mental health as established by medical history and physical examination
- Subject understands the scope of the study and agrees to strictly adhere to the study related diet plan
- Written informed consent
Exclusion
- Pregnancy or breastfeeding.
- Lack of willingness or capacity to co-operate appropriately
- Regular use of medications in the previous 2 months (except oral contraception)
- History of malignancies within the past two years or on current anticancer treatment
- History of gastrointestinal pathology such as clinically relevant gastritis, gastric ulcers, inflammatory bowel disease, chronic constipation
- History of diarrhoea within the past 14 days of screening
- History of gastrointestinal surgery with exception of appendectomy
- History of any chronic liver disease
- History of autoimmune disease requiring treatment within the past two months of screening
- Known symptomatic food allergies
- Active infection (including HIV and hepatitis B or C), or abnormalities in laboratory testing, vital signs, or physical examination
- Hypersensitivity to aluminium and/or silicon
- Chronic renal disease requiring dialysis
- Alcohol, cigarette or drug abuse
- Presence of any condition that impacts compliance with the study procedures
- Use of any investigational or non-registered product (drug or device) within 30 days preceding the first study product administration, or planned use during the study period
- Employee at the study site, spouse/partner or relative of any study staff (e.g. investigator, sub-investigators, or study nurse) or relationship to the sponsor
Key Trial Info
Start Date :
August 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2020
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04494178
Start Date
August 18 2020
End Date
November 4 2020
Last Update
November 16 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria