Vitamin D Deficiency Clinical Trial
Official title:
A Two Period, One-sequence Open-label Study of a Newly Developed Calcium Carbonate-vitamin D3 Chewable Tablet Formulation (Calcium 500 mg and Vitamin D3 800) Dosed for Three Days to Investigate the Effect on Urine Calcium and Serum Parathyroid Hormone (PTH) as Measurements of Intestinal Calcium Absorption in Healthy Postmenopausal Women and Healthy Men Compared to Baseline.
The purpose of this study is to demonstrate that the intestinal absorption of calcium from a newly developed calcium carbonate-vitamin D3 chewable tablet formulation increases the amount of calcium excreted in urine and decreases parathyroid hormone (PTH) in serum as compared to baseline.
The drug being tested in this study is called Calcichew. This study will look at calcium
absorption in healthy postmenopausal women and healthy men.
The study will enroll approximately 55 healthy adults. All participants will receive
Calcichew.
All participants will be asked to take one chewable tablet at the same time each day for
three days in period 2 of the trial.
This trial will be conducted at one clinical site in Germany. The overall time to
participate in this study is 4 weeks. Participants will make 9 visits to the clinic, and
will be contacted by telephone 7days after last dose of study drug for a follow-up
assessment.
;
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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