Status:
COMPLETED
Bioequivalence Study Comparing Calcium Acetate Oral Solution Versus Calcium Acetate Gelcaps in Healthy Volunteers
Lead Sponsor:
Fresenius Medical Care North America
Conditions:
Hyperphosphatemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00742820
Start Date
August 1 2008
End Date
November 1 2008
Last Update
February 9 2009
Active Locations (1)
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1
Community Research
Cincinnati, Ohio, United States, 45206