NCT00742820

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

February 9, 2009

Status Verified

February 1, 2009

Enrollment Period

3 months

First QC Date

August 26, 2008

Last Update Submit

February 6, 2009

Conditions

Hyperphosphatemia

Keywords

bioequivalence

Outcome Measures

Primary Outcomes (2)

  • Serum Phosphate

    24 hrs

  • Urinary Calcium

    24 hrs

Secondary Outcomes (3)

  • Serum Calcium

    24 hrs

  • Urinary Phosphate

    24 hrs

  • Serum insulin and glucose

    6 hrs

Study Arms (3)

1

EXPERIMENTAL

Calcium Acetate Oral Solution 667 mg per 5 mL

Drug: Calcium Acetate Oral Solution 667 mg per 5 mL

2

ACTIVE COMPARATOR

Calcium Acetate 667 mg Gelcaps

Drug: Calcium Acetate 667 mg GelCaps

3

OTHER

Calcium Citrate 950 mg Caplets

Dietary Supplement: Calcium Citrate 950 mg Caplets

Interventions

Calcium Acetate Oral Solution 667 mg per 5 mLDRUG

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

1
Calcium Acetate 667 mg GelCapsDRUG

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.

2
Calcium Citrate 950 mg CapletsDIETARY_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

3

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed and dated informed consent form
  • Ages: 18-75 years
  • Serum Calcium level 8.6-10.2 mg/dL
  • vitamin D level 20-100 ng/mL
  • , 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
  • +3 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Research

Cincinnati, Ohio, 45206, United States

Location

MeSH Terms

Conditions

Hyperphosphatemia

Interventions

calcium acetateCalcium Citrate

Condition Hierarchy (Ancestors)

Phosphorus Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Calcium CompoundsInorganic ChemicalsCitric AcidCitratesTricarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Antoinette A. Pragalos, MD

    Community Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 26, 2008

First Posted

August 28, 2008

Study Start

August 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

February 9, 2009

Record last verified: 2009-02

Locations

US(1)