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

NCT ID: NCT00742820

Last Updated: 2009-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2008-11-30

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.

Conditions

Hyperphosphatemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Calcium Acetate Oral Solution 667 mg per 5 mL

Group Type: EXPERIMENTAL

Calcium Acetate Oral Solution 667 mg per 5 mL

Intervention Type: DRUG

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

2

Calcium Acetate 667 mg Gelcaps

Group Type: ACTIVE_COMPARATOR

Calcium Acetate 667 mg GelCaps

Intervention Type: DRUG

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.

3

Calcium Citrate 950 mg Caplets

Group Type: OTHER

Calcium Citrate 950 mg Caplets

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Calcium 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

Intervention Type: DRUG

Calcium 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.

Intervention Type: DRUG

Calcium 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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fresenius Medical Care North America

INDUSTRY

Sponsor Role: lead

Responsible Party

Fresenius USA Manufacturing Inc., d/b/a Fresenius Medical Care North America

Principal Investigators

Antoinette A. Pragalos, MD

Role: PRINCIPAL_INVESTIGATOR

Community Research

Locations

Community Research

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

LP-RTG-01-01

Identifier Type: -

Identifier Source: org_study_id