NCT06288334招募中4 期
Exploration of the Optimal Dosage of Cetirizine in the Treatment of Allergic Diseases in Chinese Children
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Plasma concentration
研究概览
简要总结
To obtain the pharmacokinetics of cetirizine in Chinese children with allergic disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The informed consent form was voluntarily signed by the legal guardians of the subjects (children aged ≥8 years should participate in the informed consent process and sign the informed consent form).
- •Pediatric patients, whether they are outpatients or inpatients, who require oral cetirizine therapy.
- •The children was clinically diagnosed with allergic diseases such as eczema, urticaria, asthma, and allergic rhinitis.
- •Pediatric patients had not taken other antiallergic drugs 72 hours before screening.
排除标准
- •Abnormal liver function (ALT or AST > 2 times the upper limit of normal).
- •Abnormal renal function (serum creatinine above the upper limit of normal or GFR < 10 mL/min)
- •Electrolyte abnormalities (potassium or magnesium < 0.8 times lower limit of normal, > 1.2 times upper limit of normal)
- •Children who were allergic to cetirizine or had a history of serious adverse reactions.
- •Pediatric patients with unstable vital signs.
结局指标
主要结局
Plasma concentration
时间窗: 0.5 ~ 48 hours before and after administration
次要结局
未报告次要终点
研究者
Dongyang Liu
Principal Investigator
Peking University Third Hospital
研究点 (1)
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