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Bioequivalence Study Comparing Calcium Acetate Oral Solution Versus Calcium Acetate Gelcaps in Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00742820
First Posted: August 28, 2008
Last Update Posted: February 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Fresenius Medical Care North America
  Purpose
To compare the bioequivalence of calcium acetate oral solution vs. calcium acetate gelcaps in healthy volunteers with calcium citrate as a positive control.

Condition Intervention Phase
Hyperphosphatemia Drug: Calcium Acetate Oral Solution 667 mg per 5 mL Drug: Calcium Acetate 667 mg GelCaps Dietary Supplement: Calcium Citrate 950 mg Caplets Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Fresenius Medical Care North America:

Primary Outcome Measures:
  • Serum Phosphate [ Time Frame: 24 hrs ]
  • Urinary Calcium [ Time Frame: 24 hrs ]

Secondary Outcome Measures:
  • Serum Calcium [ Time Frame: 24 hrs ]
  • Urinary Phosphate [ Time Frame: 24 hrs ]
  • Serum insulin and glucose [ Time Frame: 6 hrs ]

Enrollment: 46
Study Start Date: August 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Calcium Acetate Oral Solution 667 mg per 5 mL
Drug: Calcium Acetate Oral Solution 667 mg per 5 mL
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
Active Comparator: 2
Calcium Acetate 667 mg Gelcaps
Drug: Calcium Acetate 667 mg GelCaps
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.
3
Calcium Citrate 950 mg Caplets
Dietary Supplement: Calcium Citrate 950 mg Caplets
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

  Eligibility

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00742820


Locations
United States, Ohio
Community Research
Cincinnati, Ohio, United States, 45206
Sponsors and Collaborators
Fresenius Medical Care North America
Investigators
Principal Investigator: Antoinette A. Pragalos, MD Community Research
  More Information

Responsible Party: Jonathan Greenberg, MD, Director Clinical Research, Fresenius USA Manufacturing Inc., d/b/a Fresenius Medical Care North America
ClinicalTrials.gov Identifier: NCT00742820     History of Changes
Other Study ID Numbers: LP-RTG-01-01
First Submitted: August 26, 2008
First Posted: August 28, 2008
Last Update Posted: February 9, 2009
Last Verified: February 2009

Keywords provided by Fresenius Medical Care North America:
bioequivalence

Additional relevant MeSH terms:
Hyperphosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases
Pharmaceutical Solutions
Calcium, Dietary
Citric Acid
Calcium acetate
Bone Density Conservation Agents
Physiological Effects of Drugs
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action