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Bioequivalence Study Comparing Calcium Acetate Oral Solution Versus Calcium Acetate Gelcaps in Healthy Volunteers
This study has been completed.
Study NCT00742820   Information provided by Fresenius Medical Care North America
First Received: August 26, 2008   Last Updated: February 6, 2009   History of Changes

August 26, 2008
February 6, 2009
August 2008
November 2008   (final data collection date for primary outcome measure)
  • Serum Phosphate [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
  • Urinary Calcium [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00742820 on ClinicalTrials.gov Archive Site
  • Serum Calcium [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
  • Urinary Phosphate [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
  • Serum insulin and glucose [ Time Frame: 6 hrs ] [ Designated as safety issue: No ]
Same as current
 
Bioequivalence Study Comparing Calcium Acetate Oral Solution Versus Calcium Acetate Gelcaps in Healthy Volunteers
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

To compare the bioequivalence of calcium acetate oral solution vs. calcium acetate gelcaps in healthy volunteers with calcium citrate as a positive control.

 
Phase I
Interventional
Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study
Hyperphosphatemia
  • Drug: Calcium Acetate Oral Solution 667 mg per 5 mL
  • Drug: Calcium Acetate 667 mg GelCaps
  • Dietary Supplement: Calcium Citrate 950 mg Caplets
  • Experimental: Calcium Acetate Oral Solution 667 mg per 5 mL
  • Active Comparator: Calcium Acetate 667 mg Gelcaps
  • Other: Calcium Citrate 950 mg Caplets
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
46
November 2008
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00742820
Jonathan Greenberg, MD, Director Clinical Research, Fresenius USA Manufacturing Inc., d/b/a Fresenius Medical Care North America
LP-RTG-01-01
Fresenius Medical Care North America
 
Principal Investigator: Antoinette A. Pragalos, MD Community Research
Fresenius Medical Care North America
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP