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.

Study Overview

• Status: Completed
• Conditions: Hyperphosphatemia
• Intervention / Treatment: Drug: Calcium Acetate Oral Solution 667 mg per 5 mL; Drug: Calcium Acetate 667 mg GelCaps; Dietary supplement: Calcium Citrate 950 mg Caplets

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45206
      • Community Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum Phosphate	24 hrs
Urinary Calcium	24 hrs

Secondary Outcome Measures

Outcome Measure	Time Frame
Serum Calcium	24 hrs
Urinary Phosphate	24 hrs
Serum insulin and glucose	6 hrs

Collaborators and Investigators

• Sponsor: Fresenius Medical Care North America
• Investigators: Principal Investigator: Antoinette A. Pragalos, MD, Community Research

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: August 26, 2008
• First Submitted That Met QC Criteria: August 27, 2008
• First Posted (Estimate): August 28, 2008

Study Record Updates

• Last Update Posted (Estimate): February 9, 2009
• Last Update Submitted That Met QC Criteria: February 6, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: bioequivalence
• Additional Relevant MeSH Terms: Metabolic Diseases; Phosphorus Metabolism Disorders; Hyperphosphatemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Chelating Agents; Sequestering Agents; Calcium; Calcium, Dietary; Calcium acetate
• Other Study ID Numbers: LP-RTG-01-01