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...
Calcium and Vitamin D3 is a small molecule combination product being studied for calcium deficiency. It pairs calcium with vitamin D3, which supports calcium absorption. Takeda Pharmaceutical Company Limited is developing it, and the program has been investigated in a Phase 1 human pharmacology trial in healthy participants.
Calcium and Vitamin D3 is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company sponsored a Phase 1 human pharmacology trial of the calcium and vitamin D3 tablet in healthy participants.
Calcium and Vitamin D3 is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The completed study was a human pharmacology trial of the calcium and vitamin D3 tablet conducted in healthy participants in Germany.
Calcium and Vitamin D3 has been evaluated in one completed Phase 1 trial, NCT01639222, titled Human Pharmacology Trial of Calcium-vitamin D3 Tablet in Healthy Participants. The study enrolled 55 healthy volunteers aged 45 years and older in Germany and included participants with calcium deficiency and vitamin D deficiency.