Bioequivalence Study Comparing Calcium Acetate Oral Solution Versus Calcium Acetate Gelcaps in Healthy Volunteers - Full Text View

Purpose

To compare the bioequivalence of calcium acetate oral solution vs. calcium acetate gelcaps in healthy volunteers with calcium citrate as a positive control.

Condition	Intervention	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 I

Drug Information available for:

Calcium gluconate Acetic acid, calcium salt Citric acid Sodium Citrate Calcium citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study

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

Further study details as provided by Fresenius Medical Care North America:

Primary Outcome Measures:

Serum Phosphate [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
Urinary Calcium [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Serum Calcium [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
Urinary Phosphate [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
Serum insulin and glucose [ Time Frame: 6 hrs ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	August 2008
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Active Comparator 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.
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

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742820

Contacts


Contact: Gail Kushner, RN, BSN	513-281-3868	gkushner@communityresearch.com

Locations


United States, Ohio
	Community Research	Recruiting
	Cincinnati, Ohio, United States, 45206
	Contact: Gail Kushner, RN, BSN 513-281-3868 gkushner@communityresearch.com
	Principal Investigator: Antoinette A. Pragalos, MD

Sponsors and Collaborators

Fresenius Medical Care North America

Investigators


Principal Investigator:	Antoinette A. Pragalos, MD	Community Research

More Information

Responsible Party:	Fresenius USA Manufacturing Inc., d/b/a Fresenius Medical Care North America ( Jonathan Greenberg, MD, Director Clinical Research )
Study ID Numbers:	LP-RTG-01-01
First Received:	August 26, 2008
Last Updated:	August 27, 2008
ClinicalTrials.gov Identifier:	NCT00742820
Health Authority:	United States: Food and Drug Administration

Keywords provided by Fresenius Medical Care North America:

bioequivalence

Study placed in the following topic categories:

Metabolic Diseases

Citric Acid

Hyperphosphatemia

Healthy

Metabolic disorder

Calcium acetate

Additional relevant MeSH terms:

Phosphorus Metabolism Disorders

Molecular Mechanisms of Pharmacological Action

Chelating Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on December 02, 2008

Sponsored by:	Fresenius Medical Care North America
Information provided by:	Fresenius Medical Care North America
ClinicalTrials.gov Identifier:	NCT00742820