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

Inclusion Criteria

• Is a healthy postmenopausal woman (last menses at least 2 years before signing informed consent and follicle stimulating hormone (FSH) confirming postmenopausal status) or a healthy male aged between 45 to 70 years inclusively
• Was informed both verbally and in writing about the objectives of the clinical trial, the methods, the anticipated benefits and potential risks and the discomfort to which she/he might be exposed, and had given written consent to participation in the trial prior to any trial-related procedure
• Is Caucasian
• Is assessed as healthy based on physical examination, medical history, clinical laboratory, electrocardiogram (ECG), vital signs
• Is a non-smoker (having abstained from smoking for at least 6 months)
• Has a body mass index of 19 to 29.4 kg/m^2 (inclusively)

Exclusion Criteria

• Has a history of clinically significant allergies or idiosyncrasies to calcium or vitamin D3, or any inactive ingredient(s) of these products
• Is a lactating or pregnant female participant
• Female participants: Has a positive pregnancy test in serum at screening and in urine on Day -1 Period 1
• Participant was previously enrolled into the current clinical trial
• 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
• 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
• 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)
• Has a hypersensitivity to soya or peanut
• Abuse of alcohol or drugs
• Has consumed ethanol within 48 hours prior to hospitalization verified by alcohol breath test (Alcotest®)
• 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
• Has creatinine clearance according to Modification of Diet in Renal Disease (MDRD) equation of < 60 mL/min
• 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
• 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
• 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
• Has unusual diet habits and practicing vegetarians
• 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
• Has chinine, grapefruit- and star fruit-containing beverages and food, St. John's wort (known Cytochrome P450 (CYP450) i