NCT01639222

Human Pharmacology Trial of Calcium-vitamin D3 Tablet in Healthy Participants

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 45 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Calcium Deficiency
• Vitamin D Deficiency

Interventions

Type	Name	Description
DRUG	Calcium 500 mg and Vitamin D3 800 IU	Calcium 500 mg and Vitamin D3 800 IU chewable tablets
OTHER	Low calcium meals	A normal Western European diet with reduced calcium content (400 mg per day).

Timeline

• Start date: 2012-07-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2012-07-12
• Last updated: 2013-10-18
• Results posted: 2013-10-18

Locations

1 site across 1 country: Germany