NCT00742820已完成1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Serum Phosphate
研究概览
简要总结
To compare the bioequivalence of calcium acetate oral solution vs. calcium acetate gelcaps in healthy volunteers with calcium citrate as a positive control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
1
Experimental
Calcium Acetate Oral Solution 667 mg per 5 mL
干预措施: Calcium Acetate Oral Solution 667 mg per 5 mL (Drug)
2
Active Comparator
Calcium Acetate 667 mg Gelcaps
干预措施: Calcium Acetate 667 mg GelCaps (Drug)
3
Other
Calcium Citrate 950 mg Caplets
干预措施: Calcium Citrate 950 mg Caplets (Dietary Supplement)
结局指标
主要结局
Serum Phosphate
时间窗: 24 hrs
Urinary Calcium
时间窗: 24 hrs
次要结局
- Serum insulin and glucose(6 hrs)
- Urinary Phosphate(24 hrs)
- Serum Calcium(24 hrs)
研究者
研究点 (1)
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