NCT03399084已完成1 期
An Open-label, Randomized, Parallel, Bioequivalence Study of 750 mg Intravenous Single Dose Ferric Carboxymaltose Versus Injectafer® (750 mg Iron/15 mL Colloidal Solution) in Adult Patients With Iron Deficiency Anemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sandoz
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Bioequivalence assessed by maximum serum concentration (Cmax)of serum total iron.
研究概览
简要总结
This study will evaluate bioequivalence of two formulations of Ferric Carboxymaltose as measured by serum total iron, in adult patients with iron deficiency anemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients at least 18 - 65 years of age;
- •Patients with a body mass index (BMI) between 18.5 - 35 and with a body weight of ≥50 kg - ≤130 kg;
排除标准
- •Patients with known hypersensitivity to ferric carboxymaltose, excipients, or similar product
- •Patients with chronic kidney disease who are on dialysis of any kind.
- •If female, is pregnant or nursing.
- •Patients with blood loss leading to hemodynamic instability
- •Patients with recent parenteral iron within 3 months prior to screening.
- •Other inclusion/exclusion criteria may apply.
研究组 & 干预措施
Ferric carboxymaltose (test)
Experimental
Patients will receive a single dose of Ferric carboxymaltose
干预措施: Ferric carboxymaltose (Drug)
Ferric carboxymaltose (reference)
Active Comparator
Patients will receive a single dose of Ferric carboxymaltose
干预措施: Ferric carboxymaltose (Drug)
结局指标
主要结局
Bioequivalence assessed by maximum serum concentration (Cmax)of serum total iron.
时间窗: Up to 7 days
Measured by Cmax - The maximum plasma concentration of iron
Bioequivalence assessed by area under the serum concentration-time curve (AUC) of serum total iron.
时间窗: Up to 7 Days
Plasma Pharmacokinetics (PK) of study medication: Area Under the Plasma Concentration-time Curve (AUC)
次要结局
- Maximum serum concentration (Cmax) of serum transferrin-bound iron.(Up to 7 days)
- Time of Cmax (Tmax) of serum total iron and transferrin-bound iron(Up to 7 Days)
- Area under the serum concentration-time curve (AUC) of serum transferrin-bound iron(Up to 7 Days)
- Apparent terminal rate constant of serum total iron and transferrin-bound iron(Up to 7 Days)
- Apparent terminal half-life of serum total iron and transferrin-bound iron(Up to 7 Days)
- Systemic clearance (CL) of serum total iron and transferrin-bound iron after intravenous dosing(Up to 7 Days)
- Volume of distribution at steady state of serum total iron and transferrin-bound iron following intravenous dosing(Up to 7 Days)
- Number of patients with adverse events as a measure of safety and tolerability(Up to 7 days)
研究者
研究点 (1)
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