| August 26, 2008 |
| February 6, 2009 |
| August 2008 |
| November 2008 (final data collection date for primary outcome measure) |
- Serum Phosphate [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
- Urinary Calcium [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
|
| Same as current |
| Complete list of historical versions of study NCT00742820 on ClinicalTrials.gov Archive Site |
- 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 ]
|
| Same as current |
| |
| Bioequivalence Study Comparing Calcium Acetate Oral Solution Versus Calcium Acetate Gelcaps in Healthy Volunteers |
| 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 |
To compare the bioequivalence of calcium acetate oral solution vs. calcium acetate gelcaps in healthy volunteers with calcium citrate as a positive control. |
| |
| Phase I |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study |
| Hyperphosphatemia |
- Drug: Calcium Acetate Oral Solution 667 mg per 5 mL
- Drug: Calcium Acetate 667 mg GelCaps
- Dietary Supplement: Calcium Citrate 950 mg Caplets
|
- Experimental: Calcium Acetate Oral Solution 667 mg per 5 mL
- Active Comparator: Calcium Acetate 667 mg Gelcaps
- Other: Calcium Citrate 950 mg Caplets
|
| |
| |
| Completed |
| 46 |
| November 2008 |
| November 2008 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years to 75 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00742820 |
| Jonathan Greenberg, MD, Director Clinical Research, Fresenius USA Manufacturing Inc., d/b/a Fresenius Medical Care North America |
| LP-RTG-01-01 |
| Fresenius Medical Care North America |
|
| Principal Investigator: |
Antoinette A. Pragalos, MD |
Community Research |
|
|
| Fresenius Medical Care North America |
| February 2009 |