NCT04849026已完成1 期
A Randomized, Open Label, Multiple-dose, 2-way Crossover, Phase I Study to Compare the Safety and Pharmacokinetics Profile of WID-CLZ18 and Clozaril 100 mg Tablet (Clozapine) After Oral Administration in Schizophrenia Patients
Whanin Pharmaceutical Company1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2021年1月15日最近更新:
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
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- AUC0-12
研究概览
简要总结
This clinical study is a randomized, open label, multiple-dose, 2-way crossover, phase I (Bioequivalence) study to compare the safety and pharmacokinetics profile of WID-CLZ18 and Clozaril 100 mg tablet (Clozapine) after oral administration in schizophrenia patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females adults aged 20 to 65 years
- •Diagnosed as schizophrenia prior to the screening visit
- •On treatment with a stable dose of clozapine 200 mg/day for at least 12 weeks before the screening visit and taken at 100 mg twice daily during the study period
排除标准
- •Subjects who have a medical history specified in protocol
- •Subjects with confirmed abnormal laboratory values specified in protocol
- •Subjects who have a medication history or safety risks specified in protocol
- •Subjects who can not comply with requirements of pharmacokinetic sampling as per protocol
- •Subjects who are expected to have the prohibited concomitant medication therapy during the study period
- •Pregnant women or breast-feeding women or men and women who has possibility of pregnancy
- •Subjects who are not suitable for the clinical trial
研究组 & 干预措施
Group B
Experimental
- Period 1: Clozaril 100 mg (Clozapine)
- Period 2: WID-CLZ18
干预措施: WID-CLZ18 (Drug)
Group A
Experimental
- Period 1: WID-CLZ18
- Period 2: Clozaril 100 mg (Clozapine)
干预措施: Clozaril 100 mg (Clozapine) (Drug)
Group A
Experimental
- Period 1: WID-CLZ18
- Period 2: Clozaril 100 mg (Clozapine)
干预措施: WID-CLZ18 (Drug)
Group B
Experimental
- Period 1: Clozaril 100 mg (Clozapine)
- Period 2: WID-CLZ18
干预措施: Clozaril 100 mg (Clozapine) (Drug)
结局指标
主要结局
AUC0-12
时间窗: Up to 12 hours
Area under the concentration-time curve from zero to 12 hours at steady state
Cmax
时间窗: Up to 12 hours
Maximum blood concentration in steady state
次要结局
- R(Up to 12 hours)
- Tmax(Up to 12 hours)
- T1/2(Up to 12 hours)
- Cmin(Up to 12 hours)
- Fluctuation(Up to 12 hours)
研究者
研究点 (1)
Loading locations...
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