Pharmacokinetics of Clozapine and Norclozapine and the Effect of Pantoprazole
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax)
研究概览
简要总结
Clozapine is an effective treatment for patients with schizophrenia who do not respond to other therapies, but its blood concentration varies widely between individuals due to genetic and physiological differences. Proton pump inhibitors such as pantoprazole are often prescribed in this population to prevent stomach discomfort, yet their impact on clozapine exposure has not been fully characterized. This clinical study will investigate the pharmacokinetics of clozapine and its main metabolite norclozapine, the influence of individual characteristics on drug exposure, and the effect of pantoprazole coadministration. Healthy adult volunteers will participate in a randomized open label cross over design, receiving a single dose of clozapine alone and again after pantoprazole treatment. Outcomes include clozapine and norclozapine plasma concentration time profiles, pharmacokinetic parameters, and safety assessments.
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult volunteers aged 18 to 50 years
- •No history of chronic medical or psychiatric disease, as confirmed by baseline medical evaluation, medical history, and electrocardiogram (ECG)
- •No use of any medications for at least two weeks before study initiation
排除标准
- •Pregnant or breastfeeding women
- •Current smokers
研究组 & 干预措施
Clozapine
Single dose of 12.5 mg clozapine
干预措施: clozapine (Drug)
Clozapine and pantoprazole
Single dose of 12.5 mg clozapine after five daily doses of pantoprazole tablets 40 mg to be started four days prior to the clozapine administration
干预措施: clozapine (Drug)
Clozapine and pantoprazole
Single dose of 12.5 mg clozapine after five daily doses of pantoprazole tablets 40 mg to be started four days prior to the clozapine administration
干预措施: pantoprazole (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax)
时间窗: From pre-dose to 8 hours after a single oral dose of clozapine
Maximum plasma concentration of clozapine following a single oral dose
Area Under the Plasma Concentration-Time Curve (AUC)
时间窗: From pre-dose to 8 hours after dosing
AUC of clozapine plasma concentration from time zero to the last measurable concentration following a single oral dose
次要结局
- Area Under the Concentration-Time Curve Extrapolated to Infinity (AUCinf)(From pre-dose to last measurable concentration)
- Time to Peak Concentration (Tmax)(From pre-dose to 8 hours after dosing)
研究者
Orwa Albitar
Principal Investigator
Universiti Sains Malaysia