At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 27 enrolled
Drug / intervention
Calcichew D3 +1 moredrug
Likely dose
Calcichew D3 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Calcichew D3 and Noncarbonated Water for Healthy Volunteers. Completed, enrolled 27 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesFrance
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJan 2015
First PostedJan 2015
Primary CompletionFeb 2015
TodayJul 2026
First PostedJan 14, 2015
Enrollment StartJan 1, 2015
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 11.5 years ago
Interventions
Calcichew D3drug
Calcium 500 mg and vitamin D3 1000 IU chewable tablets
Noncarbonated Waterdrug
Noncarbonated water 200 mL