Healthy Volunteers Clinical Trial
Official title:
A Single-Sequence, 2-Period, Open-Label Study of a Novel Calcium 500 mg and Vitamin D3 1000 IU Chewable Tablet Dosed for 3 Days to Investigate the Effect on Intestinal Calcium Absorption in Healthy Postmenopausal Women and Healthy Men
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 mg and vitamin D3 1000 IU) increases the amount of calcium excreted in urine and decreases parathyroid hormone (PTH) in serum as compared with Baseline.
The drug being tested in this study is called Calcichew D3. Calcichew D3 is being tested to
assess how it is processed by the body in healthy men and postmenopausal women. This study
will look at lab results in people who take Calcichew D3.
The study will enroll approximately 27 patients. All participants will receive the same
treatment:
• Calcichew D3 (calcium 500 mg and vitamin D3 1000 IU) chewable tablets All participants
will be asked to take one tablet each morning of the treatment period.
This single-centre trial will be conducted in France. The overall time to participate in
this study is up to 44 days. Participants will make 2 visits to the clinic, including one
7-day period of confinement to the clinic, and will be contacted by telephone 14 days 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: Basic Science
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