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

NCT02338713 Phase 1 COMPLETED Results posted

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.

Details

Lead sponsor	Takeda
Phase	Phase 1
Status	COMPLETED
Enrolment	27
Start date	2015-01
Completion	2015-02

Conditions

• Healthy Volunteers

Interventions

• Calcichew D3
• Noncarbonated Water

Primary outcomes

• PTH AUC(0-6): Area Under the Serum Concentration-Time Curve From Time 0 to 6 Hours for Parathyroid Hormone — Days 3 and 6: pre-dose and at multiple time-points (upto 6 hours) postdose. Day 3 for the noncarbonated water reporting group and Day 6 for the Calcichew D3 reporting group
  The PTH AUC(0-6) is a measure of the area under the serum concentration-time curve from 0 to 6 hours of parathyroid hormone.
• (Ca^2+ Ae6): Amount of Calcium Excreted in Urine From Time 0 to 6 Hours Post-dose — Days 3 and 6: pre-dose and at multiple time-points (upto 6 hours) postdose. Day 3 for the noncarbonated water reporting group and Day 6 for the Calcichew D3 reporting group
  Ca\^2+ Ae6 was calculated as the urine volume of the urine collected from 0 to 6 hours multiplied by the calcium concentration measured in urine.

Countries

France