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Human Pharmacology Trial of Calcium-vitamin D3 Tablet in Healthy Participants

NCT01639222 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2013-10-18

Study results available
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Summary

The purpose of this study is to demonstrate that the intestinal absorption of calcium from a newly developed calcium carbonate-vitamin D3 chewable tablet formulation increases the amount of calcium excreted in urine and decreases parathyroid hormone (PTH) in serum as compared to baseline.

Conditions

  • Calcium Deficiency
  • Vitamin D Deficiency

Interventions

DRUG

Calcium 500 mg and Vitamin D3 800 IU

Calcium 500 mg and Vitamin D3 800 IU chewable tablets

OTHER

Low calcium meals

A normal Western European diet with reduced calcium content (400 mg per day).

Sponsors & Collaborators

Principal Investigators

  • Principal, Clinical Pharmacology · Takeda

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01639222 on ClinicalTrials.gov