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NCT Number: NCT00742820

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

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

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Key information

Conditions

Hyperphosphatemia Metabolic Diseases Nutritional and Metabolic Diseases Phosphorus Metabolism Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Community Research

Cincinnati, Ohio, 45206, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calcium Acetate Oral Solution 667 mg per 5 mL

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

Calcium Acetate 667 mg GelCaps

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.

Calcium Citrate 950 mg Caplets

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

Primary outcomes

  1. Serum Phosphate

    Time frame: 24 hrs

  2. Urinary Calcium

    Time frame: 24 hrs

Secondary outcomes

  1. Serum Calcium

    Time frame: 24 hrs

  2. Urinary Phosphate

    Time frame: 24 hrs

  3. Serum insulin and glucose

    Time frame: 6 hrs

Sponsors and collaborators

Lead sponsor

Fresenius Medical Care North America

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Aug 28, 2008
Registry last updated
Feb 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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