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

Hyperphosphatemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00742820
• Other study ID #: LP-RTG-01-01
• Status: Completed
• Phase: Phase 1
• First received: August 26, 2008
• Last updated: February 6, 2009
• Start date: August 2008
• Est. completion date: November 2008

Study information

• Verified date: February 2009
• Source: Fresenius Medical Care North America
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperphosphatemia

Intervention

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
• 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.

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

Locations

Country	Name	City	State
United States	Community Research	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Medical Care North America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Phosphate		24 hrs	No
Primary	Urinary Calcium		24 hrs	No
Secondary	Serum Calcium		24 hrs	No
Secondary	Urinary Phosphate		24 hrs	No
Secondary	Serum insulin and glucose		6 hrs	No