Pharmacokinetics of Calcifediol and Cholecalciferol

This is an interventional treatment trial for Osteoporosis Read More

Inclusion Criteria:

• Healthy males >50 years in age
• Healthy postmenopausal women >50 years in age, who have not experienced a menstrual bleeding for a minimum of 12 months
• BMI between 20-32 kg/m2
• Subject understands the study procedures and signs the informed consent to participate in the study
• Subject has clear understanding of the English language
• Caucasian ethnicity
• Willingness to avoid direct sun exposure and to restrict travel to sunny climates during the whole study period.

Exclusion Criteria:

• Subject has any health conditions that would prevent him/her from fulfilling the study requirements, put the subject at risk or would confound the interpretation of the study results as judged by the Principal Investigator
• Subjects with a history of hypercalcemia (Serum calcium adjusted for albumin of > 2.6 nmol/l)
• Supplemental calcium intake beyond 500 mg per day during the entire study and follow up
• Any vitamin D supplementation within 2 months before the baseline blood draw and during the entire study and follow up
• Subject has gastrointestinal malabsorption (from coeliac disease, colitis, surgery etc.)
• Subject has kidney disease or liver disease
• Medication: Bisphosphonate or Parathyroid Hormone (PTH) treatment, use of steroids in any form, anticonvulsants, antibiotics, antipsychotics, use of any drug that alters fat absorption, e.g. Xenical (Ali).
• Use of Hormone Replacement Therapy (HRT) within the previous 6 months
• Subject has signs of acute or severe illness (i.e. unintentional weight loss, night sweats etc.)
• Subject has a known allergy or sensitivity to the investigational products or any ingredients of the investigational products
• Subject heavily consumes alcohol containing products defined as greater than (>) 3 drinks for men or 2 drinks for women (1 drink is 11 grams of alcohol or equivalence of 12 oz beer, 5 oz wine, or 1.5 oz distilled spirits) of alcoholic beverages per day
• Subject has donated more than 300 mL of blood during the last three months prior to screening
• Participating in another clinical trial
• Women who are premenopausal
• Subjects with active current psychiatric illness or condition which is likely to interfere with the subject's ability to understand the requirements of the biomedical research project
• Sunbed users will be excluded from the study.
• (Expected) increase in exposure to sunlight (e.g. a planned holiday of more than eight days, a beach holiday or a holiday outside Europe) in the study period of day 01 until day 28.