Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Calcium and Vitamin D3 · 1 trial · 2 indications
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.
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.
| Arm | Type | Description |
|---|---|---|
| Calcium 500 mg and Vitamin D3 800 IU | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| Calcium 500 mg and Vitamin D3 800 IU | DRUG | Calcium 500 mg and Vitamin D3 800 IU chewable tablets |
| Low calcium meals | OTHER | A normal Western European diet with reduced calcium content (400 mg per day). |
Inclusion Criteria: 1. Is a healthy postmenopausal woman (last menses at least 2 years before signing informed consent and follicle stimulating hormone (FSH) confirming postmenopausal status) or a healthy male aged between 45 to 70 years inclusively 2. Was informed both verbally and in writing abou...