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Trial record 52 of 1357 for:    Area Under Curve AND tablet

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

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ClinicalTrials.gov Identifier: NCT01639222
Recruitment Status : Completed
First Posted : July 12, 2012
Results First Posted : October 18, 2013
Last Update Posted : October 18, 2013
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Calcium Deficiency
Vitamin D Deficiency
Interventions Drug: Calcium 500 mg and Vitamin D3 800 IU
Other: Low calcium meals
Enrollment 55
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Calcium 500 mg and Vitamin D3 800 IU
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 55
Completed 55
Not Completed 0
Arm/Group Title Calcium 500 mg and Vitamin D3 800 IU
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 55
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants
57.07  (7.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
Female
22
  40.0%
Male
33
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 55 participants
55
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 55 participants
172.71  (8.97)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 55 participants
77.28  (10.06)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m²
Number Analyzed 55 participants
25.87  (2.33)
Creatinine Clearance  
Mean (Standard Deviation)
Unit of measure:  mL/min/1.73 m²
Number Analyzed 55 participants
86.60  (14.85)
1.Primary Outcome
Title Amount of Calcium Excreted in Urine From 0 Hours up to 6 Hours Post Dose (Ca2+ Ae0-6h)
Hide Description 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.
Time Frame Day 3 of Period 1 (Reference) and Day 3 in Period 2. Samples were taken 0-6 Hours post dose
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Hide Analysis Population Description
The Pharmacokinetic/Pharmacodynamic (PK/PD) Set included all enrolled subjects who received at least one dose of the mock treatment who had reliable values of either the primary PK parameter Ca2+ Ae0-6h in both periods or the primary PD parameter PTH AUC0-6h in both periods.
Arm/Group Title Calcium 500 mg and Vitamin D3 800 IU Reference Treatment
Hide Arm/Group Description:
Period 2 (Days 4-6): Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily, followed by 200 mL of non-carbonated water, for up to 3 days with low calcium meals.
Period 1 (Days 1-3): 200 mL of non-carbonated water (mock treatment) with low calcium meals for up to 3 days.
Overall Number of Participants Analyzed 55 55
Mean (Standard Deviation)
Unit of Measure: mmol
1.07  (0.49) 0.63  (0.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Calcium 500 mg and Vitamin D3 800 IU, Reference Treatment
Comments The primary parameters were analysed in a mixed effects general linear model of the logtransformed values, including treatment as a fixed effect and subject as a random effect. The objective of the trial was met if the treatment contrast was statistically significantly different from 0 in the appropriate direction in a 2-sided test on a 5% significance level for both parameters. The 5% significance level for both primary parameters was not adjusted for multiple testing.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Calcium-Vitamin D/Reference (%)
Estimated Value 179.72
Confidence Interval (2-Sided) 95%
157.16 to 205.52
Estimation Comments Point estimates and 95% CIs for the treatment difference ratio (Calcium-Vitamin D/reference treatment) are provided on the original scale as a ratio * 100%.
2.Primary Outcome
Title Area Under the Curve From 0 to 6 Hours Post Dose of Parathyroid Hormone (PTH AUC0-6h) in Serum
Hide Description 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.
Time Frame Day 3 in Period 1 (Reference) and Day 3 in Period 2. Samples were taken at predose, 0.5, 1, 2, 3, 4, and 6 hour post dose.
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Hide Analysis Population Description
PK/PD set
Arm/Group Title Calcium 500 mg and Vitamin D3 800 IU Reference Treatment
Hide Arm/Group Description:
Period 2 (Days 4-6): Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily, followed by 200 mL of non-carbonated water, for up to 3 days with low calcium meals.
Period 1 (Days 1-3): 200 mL of non-carbonated water (mock treatment) with low calcium meals for up to 3 days.
Overall Number of Participants Analyzed 55 55
Mean (Standard Deviation)
Unit of Measure: h*pg/mL
202.02  (63.51) 278.86  (79.71)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Calcium 500 mg and Vitamin D3 800 IU, Reference Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Calcium-Vitamin D/Reference (%)
Estimated Value 71.77
Confidence Interval (2-Sided) 95%
68.83 to 74.84
Estimation Comments Point estimate and 95% CI for the treatment difference ratio (Calcium-Vitamin D /reference treatment) are provided on the original scale as a ratio * 100%.
3.Secondary Outcome
Title Amount of Calcium Excreted in Urine From 0 to 6 Hours Post Dose Corected for Creatinine (Ae0-6h/Creatinine)
Hide Description To account for potential inaccuracies in urine collection, creatinine correction of calcium excretion was also assessed. Ca2+ Ae0-6h/Creatinine was obtained by dividing the urinary concentration of calcium by the urinary creatinine concentration.
Time Frame Day 3 of Period 1 (Baseline) and Day 3 in Period 2. Samples will be taken 0-6 Hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK/PD set
Arm/Group Title Calcium 500 mg and Vitamin D3 800 IU Reference Treatment
Hide Arm/Group Description:
Period 2 (Days 4-6): Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily, followed by 200 mL of non-carbonated water, for up to 3 days with low calcium meals.
Period 1 (Days 1-3): 200 mL of non-carbonated water (mock treatment) with low calcium meals for up to 3 days.
Overall Number of Participants Analyzed 55 55
Mean (Standard Deviation)
Unit of Measure: liters
1.05  (0.92) 0.69  (0.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Calcium 500 mg and Vitamin D3 800 IU
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Calcium-Vitamin D/Reference (%)
Estimated Value 156.74
Confidence Interval (2-Sided) 95%
121.66 to 201.93
Estimation Comments Point estimates and 95% CIs for the treatment difference ratio (Calcium-Vitamin D / reference treatment) are provided on the original scale as a ratio * 100%.
Time Frame Up to 13 days.
Adverse Event Reporting Description The investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. A safety follow-up phone call was conducted 7 to 12 days after last dosing.
 
Arm/Group Title Calcium 500 mg and Vitamin D3 800 IU Reference Treatment
Hide Arm/Group Description Period 2 (Days 4-6): Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily, followed by 200 mL of non-carbonated water, for up to 3 days with low calcium meals. Period 1 (Days 1-3): 200 mL of non-carbonated water (mock treatment) with low calcium meals for up to 3 days.
All-Cause Mortality
Calcium 500 mg and Vitamin D3 800 IU Reference Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Calcium 500 mg and Vitamin D3 800 IU Reference Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)   0/55 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Calcium 500 mg and Vitamin D3 800 IU Reference Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   5/55 (9.09%)   6/55 (10.91%) 
Gastrointestinal disorders     
Diarrhoea  1  3/55 (5.45%)  0/55 (0.00%) 
Constipation  1  0/55 (0.00%)  1/55 (1.82%) 
Investigations     
Blood pressure increased  1  0/55 (0.00%)  1/55 (1.82%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  0/55 (0.00%)  1/55 (1.82%) 
Nervous system disorders     
Headache  1  1/55 (1.82%)  3/55 (5.45%) 
Dizziness  1  1/55 (1.82%)  0/55 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights therefrom or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda’s sole discretion.
Results Point of Contact
Name/Title: Sr. VP, Clinical Science
Organization: Takeda Global Research and Development Center, Inc.
Phone: 800-778-2860
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01639222     History of Changes
Other Study ID Numbers: CW-2200-401-RD
2011-005786-21 ( EudraCT Number )
U1111-1124-2328 ( Registry Identifier: WHO )
First Submitted: July 9, 2012
First Posted: July 12, 2012
Results First Submitted: March 25, 2013
Results First Posted: October 18, 2013
Last Update Posted: October 18, 2013