Clinical trial NCT00742820: Bioequivalence Study Comparing Calcium Acetate Oral Solution Versus Calcium Acetate Gelcaps in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyperphosphatemia
Keywords: bioequivalence
Lead sponsor: Fresenius Medical Care North America
Sponsor class: INDUSTRY
First posted: 2008-08-28
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Serum Phosphate
timeFrame: 24 hrs
measure: Urinary Calcium
timeFrame: 24 hrs
Secondary outcomes:
measure: Serum Calcium
timeFrame: 24 hrs
measure: Urinary Phosphate
timeFrame: 24 hrs
measure: Serum insulin and glucose
timeFrame: 6 hrs
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
Study officials:
affiliation: Community Research
name: Antoinette A. Pragalos, MD
role: PRINCIPAL_INVESTIGATOR
References: