Human Pharmacology Trial of Calcium-vitamin D3 Tablet in Healthy Participants (Osteopro)
|Calcium Deficiency Vitamin D Deficiency||Drug: Calcium 500 mg and Vitamin D3 800 IU Other: Low calcium meals||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- Amount of Calcium Excreted in Urine From 0 Hours up to 6 Hours Post Dose (Ca2+ Ae0-6h) [ Time Frame: Day 3 of Period 1 (Reference) and Day 3 in Period 2. Samples were taken 0-6 Hours post dose ]Ca2+ Ae0-6h was calculated as the urine volume of the urine collected from 0 to 6 hours multiplied by the calcium concentration measured in urine.
- Area Under the Curve From 0 to 6 Hours Post Dose of Parathyroid Hormone (PTH AUC0-6h) in Serum [ Time Frame: Day 3 in Period 1 (Reference) and Day 3 in Period 2. Samples were taken at predose, 0.5, 1, 2, 3, 4, and 6 hour post dose. ]The area under the curve from 0 to 6 hours post dose of parathyroid hormone (PTH AUC0-6h) in serum, calculated using the linear trapezoidal formula.
- Amount of Calcium Excreted in Urine From 0 to 6 Hours Post Dose Corected for Creatinine (Ae0-6h/Creatinine) [ Time Frame: Day 3 of Period 1 (Baseline) and Day 3 in Period 2. Samples will be taken 0-6 Hours postdose ]To account for potential inaccuracies in urine collection, creatinine correction of calcium excretion was also assessed. Ca2+ Ae0-6h/Creatinine was obtained by dividing the urinary concentration of calcium by the urinary creatinine concentration.
|Study Start Date:||July 2012|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Experimental: Calcium 500 mg and Vitamin D3 800 IU
Period 1: Low calcium meals for up to 3 days.
Period 2: Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily for up to 3 days with low calcium meals.
Drug: Calcium 500 mg and Vitamin D3 800 IU
Calcium 500 mg and Vitamin D3 800 IU chewable tablets
Other Name: Calcichew-D3 forte 500 mg/800 IUOther: Low calcium meals
A normal Western European diet with reduced calcium content (400 mg per day).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01639222
|Mannheim, Baden-Württemberg, Germany|
|Study Director:||Principal, Clinical Pharmacology||Takeda|