NCT00321516已完成1 期
Effects of Aripiprazole on the Steady-State Pharmacokinetics of Lamotrigine in Subjects With Bipolar I Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2006年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Comparison of Cmax (maximum drug concentration) and AUC(Tau) (exposure) of lamotrigine at the beginning of the study (Day-1) and when the subject completes the study (Day 36)
研究概览
简要总结
The purpose of this clinical research study is to learn if aripiprazole has a drug-drug interaction with lamotrigine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Body mass index (BMI) of 18 to 40 kg/m2
- •Subjects with bipolar I disorder who are clinically stable on a stable dose of at least 100 mg lamotrigine for at least 4 weeks prior to study entry
- •Men and women, ages 18 to 65
排除标准
- •Women who are pregnant or breastfeeding
- •Patients with any significant acute or chronic medical illness, other than bipolar I disorder
- •Subjects with active psychotic symptoms
- •History of head trauma within the past 2 years
- •History of akathisia requiring treatment
- •History of tardive dyskinesia or abnormal involuntary movements
- •Subjects with a predisposition to orthostatic hypotension
- •Positive urine screen for drugs of abuse
- •Use of narcotic-containing agents, amphetamines, or hormonal contraceptives within 4 weeks of study start
研究组 & 干预措施
1
Experimental
干预措施: aripiprazole (Drug)
结局指标
主要结局
Comparison of Cmax (maximum drug concentration) and AUC(Tau) (exposure) of lamotrigine at the beginning of the study (Day-1) and when the subject completes the study (Day 36)
次要结局
- Assess the safety and tolerability of aripiprazole when co-administered with lamotrigine for up to 4 weeks
研究者
研究点 (1)
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