Bioequivalence Study Comparing Calcium Acetate Oral Solution Versus Calcium Acetate Gelcaps in Healthy Volunteers
Primary Purpose
Hyperphosphatemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Calcium Acetate Oral Solution 667 mg per 5 mL
Calcium Acetate 667 mg GelCaps
Calcium Citrate 950 mg Caplets
Sponsored by
About this trial
This is an interventional treatment trial for Hyperphosphatemia focused on measuring bioequivalence
Eligibility Criteria
Inclusion Criteria:
- Signed and dated informed consent form
- Ages: 18-75 years
- Serum Calcium level 8.6-10.2 mg/dL
- 25 vitamin D level 20-100 ng/mL
- 1, 25 dihydroxy vitamin D level 6-62 pg/mL
- Fasting glucose level of 65-99 mg/dL (min 8 hr fast)
- iPTH level of 10-65 pg/mL
- Serum phosphorous level of 2.5-4.5 mg/dL
- Albumin level of 3.6-5.1 g/dL
- Sodium level of 135-146 mEq/L
- Potassium level of 3.5-5.3 mEq/L
- Negative pregnancy test (at screening and prior to dosing) for women of childbearing potential and subjects must agree to use adequate contraception (hormonal or double barrier method) during the study
- No clinically significant abnormalities on electrocardiogram (ECG) reading as determined by the INVESTIGATOR
- No clinically significant abnormalities on liver function tests
- No clinically significant abnormalities on CBC and coagulation studies
- No clinically significant abnormalities on kidney function (eGFR using serum creatinine)
- BMI between 18.5-30
- Subjects must agree not to consume alcohol while in the treatment phase of the study
Exclusion Criteria:
- Women who are pregnant or breast feeding
- Malignancy except squamous cell carcinoma of the skin
- Documented current acute or chronic disease
- Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C
- Myocardial infarction within 6 months of study Day 0
- Parathyroidectomy within 6 months of study Day 0
- Gastrointestinal disorder associated with impaired absorption of oral medications
- Inability to swallow tablets or tolerate calcium acetate oral solution
- Hormonal therapy (except for contraceptives), immunotherapy or corticoid therapy
- Concurrent antibiotic treatment
- Any concurrent investigational treatment within 30 days of screening
- Unable or unwilling to comply fully with the protocol
- Diuretic therapy such as Thiazides, Furosemide (INN) or frusemide (former BAN) within one month before screening
- Subjects taking over-the-counter (OTC) or prescribed phosphorous or calcium containing supplements
- Subjects testing positive for drugs of abuse
Sites / Locations
- Community Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
1
2
3
Arm Description
Calcium Acetate Oral Solution 667 mg per 5 mL
Calcium Acetate 667 mg Gelcaps
Calcium Citrate 950 mg Caplets
Outcomes
Primary Outcome Measures
Serum Phosphate
Urinary Calcium
Secondary Outcome Measures
Serum Calcium
Urinary Phosphate
Serum insulin and glucose
Full Information
NCT ID
NCT00742820
First Posted
August 26, 2008
Last Updated
February 6, 2009
Sponsor
Fresenius Medical Care North America
1. Study Identification
Unique Protocol Identification Number
NCT00742820
Brief Title
Bioequivalence Study Comparing Calcium Acetate Oral Solution Versus Calcium Acetate Gelcaps in Healthy Volunteers
Official Title
Randomized, Controlled, 3-Arm, Open Label, Cross-Over Bioequivalence Study Comparing Liquid PhosLo vs. PhosLo Gelcaps Using Calcium Citrate as a Positive Control in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Fresenius Medical Care North America
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare the bioequivalence of calcium acetate oral solution vs. calcium acetate gelcaps in healthy volunteers with calcium citrate as a positive control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperphosphatemia
Keywords
bioequivalence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Calcium Acetate Oral Solution 667 mg per 5 mL
Arm Title
2
Arm Type
Active Comparator
Arm Description
Calcium Acetate 667 mg Gelcaps
Arm Title
3
Arm Type
Other
Arm Description
Calcium Citrate 950 mg Caplets
Intervention Type
Drug
Intervention Name(s)
Calcium Acetate Oral Solution 667 mg per 5 mL
Intervention Description
Drug: Calcium acetate oral solution 667 mg calcium acetate, USP per 5 mL (169 mg of elemental calcium per 5 mL); Dosage: 30 mL of calcium acetate oral solution; Dosage frequency: three times per day with meals; Duration: 3 days and the morning of day 4, in total ten doses
Intervention Type
Drug
Intervention Name(s)
Calcium Acetate 667 mg GelCaps
Intervention Description
Drug: PhosLo GelCaps (calcium acetate) 667 mg (169 mg of elemental calcium per gelcap); Dosage: 6 gelcaps; Dosage frequency: three times per day with meals; Duration: 3 days and the morning of day 4, in total ten doses.
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium Citrate 950 mg Caplets
Intervention Description
Drug: Calcium Citrate 950 mg Caplets (200 mg of elemental calcium per caplet); Dosage: 5 caplets; Dosage frequency: three times per day with meals; Duration: 3 days and the morning of day 4, in total ten doses
Primary Outcome Measure Information:
Title
Serum Phosphate
Time Frame
24 hrs
Title
Urinary Calcium
Time Frame
24 hrs
Secondary Outcome Measure Information:
Title
Serum Calcium
Time Frame
24 hrs
Title
Urinary Phosphate
Time Frame
24 hrs
Title
Serum insulin and glucose
Time Frame
6 hrs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Signed and dated informed consent form
Ages: 18-75 years
Serum Calcium level 8.6-10.2 mg/dL
25 vitamin D level 20-100 ng/mL
1, 25 dihydroxy vitamin D level 6-62 pg/mL
Fasting glucose level of 65-99 mg/dL (min 8 hr fast)
iPTH level of 10-65 pg/mL
Serum phosphorous level of 2.5-4.5 mg/dL
Albumin level of 3.6-5.1 g/dL
Sodium level of 135-146 mEq/L
Potassium level of 3.5-5.3 mEq/L
Negative pregnancy test (at screening and prior to dosing) for women of childbearing potential and subjects must agree to use adequate contraception (hormonal or double barrier method) during the study
No clinically significant abnormalities on electrocardiogram (ECG) reading as determined by the INVESTIGATOR
No clinically significant abnormalities on liver function tests
No clinically significant abnormalities on CBC and coagulation studies
No clinically significant abnormalities on kidney function (eGFR using serum creatinine)
BMI between 18.5-30
Subjects must agree not to consume alcohol while in the treatment phase of the study
Exclusion Criteria:
Women who are pregnant or breast feeding
Malignancy except squamous cell carcinoma of the skin
Documented current acute or chronic disease
Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C
Myocardial infarction within 6 months of study Day 0
Parathyroidectomy within 6 months of study Day 0
Gastrointestinal disorder associated with impaired absorption of oral medications
Inability to swallow tablets or tolerate calcium acetate oral solution
Hormonal therapy (except for contraceptives), immunotherapy or corticoid therapy
Concurrent antibiotic treatment
Any concurrent investigational treatment within 30 days of screening
Unable or unwilling to comply fully with the protocol
Diuretic therapy such as Thiazides, Furosemide (INN) or frusemide (former BAN) within one month before screening
Subjects taking over-the-counter (OTC) or prescribed phosphorous or calcium containing supplements
Subjects testing positive for drugs of abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoinette A. Pragalos, MD
Organizational Affiliation
Community Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45206
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bioequivalence Study Comparing Calcium Acetate Oral Solution Versus Calcium Acetate Gelcaps in Healthy Volunteers
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