NCT06154434已完成1 期
An Open Label, Randomized, Fasting, Single-dose, Two-period Crossover Study to Compare the Bioequivalence of Chlorpromazine HCl 100mg Tablets After Oral Administration in Healthy Subjects.
Whanin Pharmaceutical Company1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年12月6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
- 70
- 试验地点
- 1
- 主要终点
- AUClast
研究概览
简要总结
This clinical study is an open label, randomized, fasting condition, single-dose, two-period crossover study to compare the bioequivalence of Chlorpromazine HCl 100mg Tablets after oral administration in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects, over the age of 19 years old
- •Weight: At least 50.0 kg and Body mass index (BMI) between 18.0-30.0 kg/m
- •All subjects should be judged normal and healthy during a pre-study medical evaluation
- •Subjects who has no birth or chronic disease and must be in good health as determined by physical exmination and medical tests including biochemistry, urinalysis, serology and hematology etc in serum/urine.
- •Subject is willing to participate and to Sign written informed consent form
- •Female subjects of childbearing age who use contraception other than hormonal contraception.
- •Subjects who has no history of psychical disorder within the last five years
排除标准
- •Subjects who have a medical history specified in protocol
- •Subjects who are expected to have the prohibited medication and activity etc. during the study period
- •Subjects who can not comply with requirements as per protocol
- •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 A
Experimental
干预措施: Chlorpromazine HCl 100mg Tablets (Drug)
Group B
Experimental
干预措施: Chlorpromazine HCl 100mg Tablets (Drug)
结局指标
主要结局
AUClast
时间窗: Up to 72 hours
Cmax
时间窗: Up to 72 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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