Conditions: Healthy Volunteers
Keywords: Drug therapy
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 27
Healthy volunteers: yes

Brief 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.

Detailed description:
The drug being tested in this study was called Calcichew D3. Calcichew D3 was being tested to assess how it is processed by the body in healthy men and postmenopausal women. This study looked at lab results in people who take Calcichew D3.

The study enrolled approximately 27 participants. All participants received the same treatment:

• Calcichew D3 (calcium 500 mg and vitamin D3 1000 IU) chewable tablets All participants were asked to take one tablet each morning of the treatment period.

This single-centre trial was conducted in France. The overall time to participate in this study was up to 44 days. Participants made 2 visits to the clinic, including one 7-day period of confinement to the clinic, and were contacted by telephone 14 days after last dose of study drug for a follow-up assessment.

Arms:
arm 1: Noncarbonated water 200 milliliter (mL), orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period) followed by Calcichew D3 500 milligram (mg)/1000 international units (IU) (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period) of 6 days treatment period.

Interventions: intervention 1: Calcichew D3 intervention 2: Noncarbonated Water
Intervention descriptions: intervention 1: Calcium 500 mg and vitamin D3 1000 IU chewable tablets intervention 2: Noncarbonated water 200 mL

Protocol document: