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Calcichew D3

Phase 1

Healthy Volunteers | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Jun 16, 2017

Success Probability

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Clinical trial landscape

Calcichew D3 · 1 trial · 1 indication

Phase 1 1
NCT02338713Effect of Calcium 500 mg and Vitamin D3 1000 IU Chewable Tablet on Intestinal Calcium AbsorptionHealthy Volunteers
COMPLETED27 Analytics
PHASE1COMPLETED
Effect of Calcium 500 mg and Vitamin D3 1000 IU Chewable Tablet on Intestinal Calcium Absorption
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Study Endpoints

Primary Endpoints

PTH AUC(0-6): Area Under the Serum Concentration-Time Curve From Time 0 to 6 Hours for Parathyroid Hormone
Days 3 and 6: pre-dose and at multiple time-points (upto 6 hours) postdose. Day 3 for the noncarbonated water reporting group and Day 6 for the Calcichew D3 reporting group

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): Amount of Calcium Excreted in Urine From Time 0 to 6 Hours Post-dose
Days 3 and 6: pre-dose and at multiple time-points (upto 6 hours) postdose. Day 3 for the noncarbonated water reporting group and Day 6 for the Calcichew D3 reporting group

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.

Secondary Endpoints

PTH AUC (0-24): Area Under the Serum Concentration-Time Curve From Time 0 to 24 Hours for Parathyroid Hormone
Days 3 and 6: pre-dose and at multiple time-points (up to 24 hours) postdose. Day 3 for the noncarbonated water reporting group and Day 6 for the calcichew D3 reporting group
(Ca^2+ Ae24): Amount of Calcium Excreted in Urine From Time 0 to 24 Hours Post-dose
Days 3 and 6: pre-dose and at multiple time-points (upto 24 hours) postdose. Day 3 for the noncarbonated water reporting group and Day 6 for the Calcichew D3 reporting group
Cmax: Maximum Observed Serum Concentration for Calcium
Days 3 and 6: predose and at multiple time-points (up to 24 hours) postdose. Day 3 for the non carbonated water reporting group and Day 6 for the Calcichew D3 reporting group
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Noncarbonated Water + Calcichew D3EXPERIMENTALNoncarbonated 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

NameTypeDescription
Calcichew D3DRUGCalcium 500 mg and vitamin D3 1000 IU chewable tablets
Noncarbonated WaterDRUGNoncarbonated water 200 mL
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Eligibility Criteria

Age Range45 Years to 70 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:France
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Frequently asked questions about Calcichew D3

What is Calcichew D3 used for?

Calcichew D3 is a chewable tablet containing calcium 500 mg and vitamin D3 1000 IU, studied in healthy volunteers. It is being investigated for its effect on intestinal calcium absorption. The drug is in Phase 1 clinical development and is not approved for any indication.

Who makes Calcichew D3?

Calcichew D3 is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical research on this product in healthy volunteers.

What phase is Calcichew D3 in?

Calcichew D3 is in Phase 1 clinical development. It is an investigational product and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and no active trials are currently ongoing.

What clinical trials is Calcichew D3 in?

Calcichew D3 has one completed clinical trial, NCT02338713, titled 'Effect of Calcium 500 mg and Vitamin D3 1000 IU Chewable Tablet on Intestinal Calcium Absorption.' This Phase 1 study enrolled 27 healthy volunteers in France, with participants aged 45 years and older.

Is Calcichew D3 the same as calcium and vitamin D3 supplements?

Calcichew D3 is a specific chewable tablet formulation containing calcium 500 mg and vitamin D3 1000 IU. It is being studied for its effect on intestinal calcium absorption in healthy volunteers. The product is in Phase 1 clinical development.