Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Calcichew D3 · 1 trial · 1 indication
The PTH AUC(0-6) is a measure of the area under the serum concentration-time curve from 0 to 6 hours of parathyroid hormone.
Ca\^2+ Ae6 was calculated as the urine volume of the urine collected from 0 to 6 hours multiplied by the calcium concentration measured in urine.
| Arm | Type | Description |
|---|---|---|
| Noncarbonated Water + Calcichew D3 | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| Calcichew D3 | DRUG | Calcium 500 mg and vitamin D3 1000 IU chewable tablets |
| Noncarbonated Water | DRUG | Noncarbonated water 200 mL |
Inclusion Criteria: 1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. 2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any requi...
Calcichew D3 is a small molecule combination product containing calcium 500 mg and vitamin D3 1000 IU in a chewable tablet. It is being developed by Takeda Pharmaceutical Company Limited. The product has been studied in a Phase 1 clinical trial in healthy volunteers to evaluate its effect on intestinal calcium absorption.
Calcichew D3 is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical trial evaluating the product. The company is a global pharmaceutical manufacturer with a portfolio spanning multiple therapeutic areas.
Calcichew D3 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The product has not been approved by the FDA for any indication and remains investigational.
Calcichew D3 has been studied in one completed Phase 1 trial, NCT02338713, titled Effect of Calcium 500 mg and Vitamin D3 1000 IU Chewable Tablet on Intestinal Calcium Absorption. The trial enrolled 27 healthy volunteers in France, included both sexes, and had a minimum age of 45 years.
Calcichew D3 is being studied for its effect on intestinal calcium absorption in healthy volunteers. The specific therapeutic indications for the product have not been disclosed. It is a combination of calcium and vitamin D3 in a chewable tablet formulation.