G-PUR® for Reduced Lead Bioavailability

Inclusion criteria

• Healthy male and female subjects
• Age 18-45 years
• BMI 19-27 for males and BMI 17-25 for female
• Blood lead (PbB) concentration < 40 μg/l
• Serum ferritin concentration within the sex-specific normal range, i.e. ≥ 15 - 150 ng/ml for women and 30 - 400 ng/ml for men
• Presence of scalp hair with a minimum length of 5 mm and willingness to remove 5 single hairs with hair roots at end of study visit
• Subject is in good clinical and mental health as established by medical history and physical examination
• Stable eating habits, within one month before the start of the study
• Subject agrees to be compliant for study related diet schedule
• Women of childbearing potential agree to use adequate birth control methods during the study (for all females, negative pregnancy test at screening and at Visit 3 before dosing of IMD is required. Females of childbearing potential must use adequate contraception during the entire study period. Acceptable methods of contraception include: oral contraceptives, intrauterine device, female or male condoms with spermicide, diaphragm with spermicide, contraceptive medication patch, contraceptive medication implant, contraceptive medication injection, abstinence, or surgical sterilization more than 3 months before randomization.
• Written informed consent

Exclusion criteria

• Pregnancy and breastfeeding
• Lack of willingness or capacity to co-operate appropriately
• Regular use of medications or iron supplements in the previous 2 months except intake of contraceptives
• Planning to shave head during study
• History of malignancies within the past two years or on current anticancer treatment
• History of gastrointestinal pathology such as gastritis, gastric ulcers, irritable bowel disease, 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 chronic autoimmune disease requiring treatment within the past two months of screening
• Known diabetes mellitus I or II or Hba1c >6.5%
• Known symptomatic food allergies
• Any clinically relevant laboratory abnormalities in screening test
• Alcohol, cigarette or drug abuse
• Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
• Presence of any condition that impacts compliance with the study procedures
• Use of any regular medication (prescription or over the counter) for prevention or treatment of any medical condition
• 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
• IMD should not be applied to patients that suffer from aluminium and/or silicon hypersensitivity or in case of renal failure that requires dialysis.