Hyperphosphatemia
Conditions
Keywords
bioequivalence
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.
Interventions
DRUGCalcium 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
DRUGCalcium 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.
DIETARY_SUPPLEMENTCalcium 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
Sponsors
Fresenius Medical Care North America
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum Phosphate | 24 hrs |
| Urinary Calcium | 24 hrs |
Secondary
| Measure | Time frame |
|---|---|
| Serum Calcium | 24 hrs |
| Urinary Phosphate | 24 hrs |
| Serum insulin and glucose | 6 hrs |
Countries
United States
Outcome results
None listed