Effect of Calcium 500 mg and Vitamin D3 1000 IU Chewable Tablet on Intestinal Calcium Absorption
Condition: Healthy Volunteers
Intervention: Calcichew D3; Noncarbonated Water
Intervention description: Calcium 500 mg and vitamin D3 1000 IU chewable tablets; Noncarbonated water 200 mL
Intervention MeSH terms: Calcium Carbonate
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 45 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

Summary:

      The purpose of this study is to demonstrate that the intestinal absorption of calcium from a
      novel calcium carbonate-vitamin D3 chewable tablet formulation (calcium 500 milligrams (mg)
      and vitamin D3 1000 International Units (IU)) increases the amount of calcium excreted in
      urine and decreases parathyroid hormone (PTH) in serum as compared with Baseline.
    

Eligibility criteria:

        Inclusion Criteria:

          1. In the opinion of the investigator, the participant is capable of understanding and
             complying with protocol requirements.

          2. The participant or, when applicable, the participant's legally acceptable
             representative signs and dates a written, informed consent form and any required
             privacy authorization prior to the initiation of any study procedures including
             requesting that a participant fast for any laboratory evaluations.

          3. Is a healthy adult male or female participant.

          4. Female participants should be postmenopausal (last menses at least 2 years before
             signing informed consent and follicle-stimulating hormone (FSH) confirming
             postmenopausal status).

          5. The participant is White.

          6. Is aged 45 to 70 years, inclusive, at the time of informed consent and study
             enrollment.

          7. Weighs at least 50 kg and has a body mass index (BMI) from 18 to 30 kilogram per
             square meter (kg/m^2), inclusive at Screening and Day -1.

          8. Is a nonsmoker (having abstained from smoking for at least 6 months).

        Exclusion Criteria:

          1. Has received any investigational compound within 30 days prior to Screening.

          2. Is an immediate family member, study site employee, or in a dependant relationship
             with a study site employee who is involved in the conduct of this study (example,
             spouse, parent, child, sibling) or may consent under duress.

          3. Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary,
             hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other
             abnormality, which may impact the ability of the participant to participate or
             potentially confound the study results.

          4. Has a known hypersensitivity to calcium or vitamin D3 or to any of the excipients of
             the formulation of the Calcichew D3 chewable tablet.

          5. Has a positive urine drug result for drugs of abuse (defined as any illicit drug use)
             at Screening or Check-in (Day -1).

          6. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol
             abuse (defined as regular consumption of 5 or more units per day) within 5 years prior
             to the Screening Visit or is unwilling to agree to abstain from alcohol and drugs
             throughout the study. One unit is equivalent to a half-pint of beer or 1 measure of
             spirits or 1 glass of wine. Ethanol consumption within 72 hours prior to Check-in (Day
             -1) verified by alcohol breath test (Alcotest).

          7. Has taken any excluded medication, supplements, or food products during the time
             periods listed in the Excluded Medications and Dietary Products table.

          8. Has current or recent (within 6 months) gastrointestinal disorder or gastrointestinal
             surgery (except appendectomy) that would be expected to influence the absorption of
             drugs and calcium (ie, a history of malabsorption, esophageal reflux, peptic ulcer
             disease, erosive esophagitis, frequent [more than once per week] occurrence of
             heartburn, or any surgical intervention [eg, cholecystectomy]).

          9. Has a history of cancer, except basal cell carcinoma that has been in remission for at
             least 5 years prior to Day 1.

         10. Has a positive test result for hepatitis B surface antigen (HBsAg), antibody to
             hepatitis C virus (anti-HCV), and human immunodeficiency virus (HIV) antibody at
             Screening.

         11. Has used nicotine-containing products (including but not limited to cigarettes, pipes,
             cigars, chewing tobacco, nicotine patch or nicotine gum) within 21 days prior to
             Check-in (Day -1). Cotinine test is positive at Screening or Check-in (Day -1).

         12. Has poor peripheral venous access.

         13. Has donated or lost 450 millileters (mL) or more of his or her blood volume (including
             plasmapheresis), or had a transfusion of any blood product within 30 days prior to Day
             1.

         14. Has a Screening or Check-in (Day -1) abnormal (clinically significant)
             electrocardiogram (ECG). Entry of any participant with an abnormal (not clinically
             significant) ECG must be approved, and documented by signature by both the principal
             investigator and the Takeda medical monitor.

         15. Has abnormal Screening or Day -1 laboratory values that suggest a clinically
             significant underlying disease or participant with the following laboratory
             abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)
             greater than (>)2.0 times the upper limit of normal (ULN).

         16. Is a practicing vegetarian or vegan.

         17. Has a creatinine clearance according to Modification of Diet in Renal Disease equation
             of less than (<)60 mL/min at Screening or Check-in (Day -1).