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

• Sponsor: Fresenius Medical Care North America (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00742820
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arms: 3
• Duration (Months): 3
• Patients Per Site Per Month: 15.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperphosphatemia	Drug: Calcium Acetate Oral Solution 667 mg per 5 mL; Drug: Calcium Acetate 667 mg GelCaps; Dietary Supplement: Calcium Citrate 950 mg Caplets	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Aug 1, 2008
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Calcium Acetate Oral Solution 667 mg per 5 mL	Drug: 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
Active Comparator: 2 Calcium Acetate 667 mg Gelcaps	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.
Other: 3 Calcium Citrate 950 mg Caplets	Dietary Supplement: 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

Outcome Measures

Primary Outcome Measures

1. Serum Phosphate [24 hrs]

2. Urinary Calcium [24 hrs]

Secondary Outcome Measures

1. Serum Calcium [24 hrs]

2. Urinary Phosphate [24 hrs]

3. Serum insulin and glucose [6 hrs]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Community Research	Cincinnati	Ohio	United States	45206

Sponsors and Collaborators

• Fresenius Medical Care North America

Investigators

• Principal Investigator: Antoinette A. Pragalos, MD, Community Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00742820
• Other Study ID Numbers: LP-RTG-01-01
• First Posted: Aug 28, 2008
• Last Update Posted: Feb 9, 2009
• Last Verified: Feb 1, 2009

• Keywords provided by , ,: bioequivalence
• Additional relevant MeSH terms: Hyperphosphatemia; Calcium, Dietary; Calcium; Calcium acetate

Study Results

No Results Posted as of Feb 9, 2009