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

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

Official Title
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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

Conditions
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Hyperphosphatemia

Intervention / Treatment
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* Drug: Calcium Acetate Oral Solution 667 mg per 5 mL
* Drug: Calcium Acetate 667 mg GelCaps
* Dietary Supplement: Calcium Citrate 950 mg Caplets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Calcium Acetate Oral Solution 667 mg per 5 mL | Drug: Calcium Acetate Oral Solution 667 mg per 5 mL<br>* 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<br>|
| Active Comparator: 2<br>Calcium Acetate 667 mg Gelcaps | Drug: Calcium Acetate 667 mg GelCaps<br>* 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.<br>|
| Other: 3<br>Calcium Citrate 950 mg Caplets | Dietary Supplement: Calcium Citrate 950 mg Caplets<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Phosphate |  | 24 hrs | 
| Urinary Calcium |  | 24 hrs | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bioequivalence