Overview

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

Status:
Completed
Trial end date:
2008-11-01
Target enrollment:
0
Participant gender:
All
Summary
To compare the bioequivalence of calcium acetate oral solution vs. calcium acetate gelcaps in healthy volunteers with calcium citrate as a positive control.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Fresenius Medical Care North America
Treatments:
Calcium
Calcium acetate
Calcium, Dietary
Citric Acid
Pharmaceutical Solutions
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