Human Pharmacology Trial of Calcium-vitamin D3 Tablet in Healthy Participants

Exclusion Criteria

• •1. Has a history of clinically significant allergies or idiosyncrasies to calcium or vitamin D3, or any inactive ingredient(s) of these products
• •2. Is a lactating or pregnant female participant
• •3. Female participants: Has a positive pregnancy test in serum at screening and in urine on Day -1 Period 1
• •4. Participant was previously enrolled into the current clinical trial
• •5. Has participated in the active treatment phase of another clinical trial where a persisting pharmacodynamic (PD) effect of the IMP of that clinical trial cannot be excluded (e.g. patient is well into a treatment free safety follow-up phase); or 10 times the pharmacokinetic (PK) half-life, whatever is longer but 30 days as minimum prior to the start of the clinical trial
• •6. Has been considered unable or unwilling to co-operate adequately, i.e. to follow clinical trial procedures and Investigator instructions adequately (e.g. language difficulties, etc.) or participant is anticipated not to be available for scheduled clinical trial visits/procedures
• •7. Has a dependency situation (e.g. person is kept in detention, Investigator in the current clinical trial, or a first-degree relative of a clinical trial Investigator, or is employee at the clinical trial site)
• •8. Has a hypersensitivity to soya or peanut
• •9. Abuse of alcohol or drugs
• •10. Has consumed ethanol within 48 hours prior to hospitalization verified by alcohol breath test (Alcotest®)
• •11. Has a history or current disease which might influence the trial objectives (e.g., urinary tract infection, urination problems \[e.g., prostate hyperplasia\] or urinary incontinence, renal insufficiency, nephrolithiasis, sarcoidosis, osteoporosis, calcium deficiency, hyper- or hypoparathyroidism, hypercalciuria, hypercalcaemia, calcium lithiasis, hyperphosphataemia, hypervitaminosis D, phenylketonuria, diabetes mellitus
• •12. Has creatinine clearance according to Modification of Diet in Renal Disease (MDRD) equation of \< 60 mL/min
• •13. Has regular use of any medication. Treatment with biphosphonates in the past 5 years, amidorone in the past 6 months, calcium or fluoride supplements, diuretics, vitamin D preparations, estrogens or estrogen receptor modulators, enzyme inducing agents, teriparatide or parathyroid hormone (PTH(1-84)), bile sequestrants within 3 months before screening, and for all other drugs within 2 weeks before screening (or 6 times the half-life of the respective drug) whatever is longer
• •14. Has use of ultraviolet radiation cabins or sunbath longer than 1 h from 1 week before Day 1 of Period 1 until the End of Trial examination
• •15. Has an intake of milk and milk products, broccoli, dark-green vegetables, vegetables from the mustard green family, fatty fish, eggs, liver, and added salt within 7 days prior to hospitalisation
• •16. Has unusual diet habits and practicing vegetarians
• •17. Has beverages and food containing poppy seed (i.e. poppy seed rolls, poppy seed cake, milk shakes containing poppy seed) from 72 hours before drug screen to avoid interference
• •18. Has chinine, grapefruit- and star fruit-containing beverages and food, St. John's wort (known Cytochrome P450 (CYP450) inhibitors and inducers) within 7 days prior to hospitalization
• •19. Has excessive consumption of caffeinated beverages (more than five cups of coffee or equivalent per day)
• •20. Has consumption of xanthine-containing beverages and food (e.g. coffee, black and green tea, cola, chocolate) 48 hours prior to hospitalization
• •21. Has evidence of acute or chronic hepatitis B or C. Positive test for hepatitis B surface antigen (HBsAg), antibody to the hepatitis B core antigen (anti-HBc) or antibody to the hepatitis C virus (anti-HCV antibody), or human immunodeficiency virus (HIV) infection at screening
• •22. Has history of gastrointestinal surgery (except appendectomy) or any other gastrointestinal condition or disease that might influence (calcium) absorption
• •23. Has any condition, including laboratory findings or findings in the medical history or screening assessments that, in the opinion of the Investigator, constitutes a specific risk or a contraindication for the participant's participation in the trial or that could interfere with the trial objectives, conduct or evaluation
• •24. Has any comedication required during the trial.