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

Phase 1

Completed

• Conditions: Hyperphosphatemia
• Interventions: Drug: Calcium Acetate 667 mg GelCaps; Drug: Calcium Acetate Oral Solution 667 mg per 5 mL; Dietary Supplement: Calcium Citrate 950 mg Caplets

• Registration Number: NCT00742820
• Lead Sponsor: Fresenius Medical Care North America

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-26
• Study First Submitted QC: 2008-08-27
• Study First Posted: 2008-08-28
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-06
• Last Update Posted: 2009-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Calcium Acetate 667 mg GelCaps	Calcium Acetate 667 mg Gelcaps
1	Calcium Acetate Oral Solution 667 mg per 5 mL	Calcium Acetate Oral Solution 667 mg per 5 mL
3	Calcium Citrate 950 mg Caplets	Calcium Citrate 950 mg Caplets

Primary Outcome Measures

Name	Time	Method
Serum Phosphate	24 hrs
Urinary Calcium	24 hrs

Secondary Outcome Measures

Name	Time	Method
Serum insulin and glucose	6 hrs
Urinary Phosphate	24 hrs
Serum Calcium	24 hrs

Trial Locations

Locations (1)

Community Research; 🇺🇸 Cincinnati, Ohio, United States