NCT01074073已完成1 期
A Phase 1, Open-Label, 2-Period, Sequential, Drug-Drug Interaction Study To Determine The Effect Of Lithium 600 Mg BID On The Safety And Pharmacokinetics Of Lurasidone 120 Mg QD In Patients With Schizophrenia Or Schizoaffective Disorder
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
- 24
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to evaluate the drug-drug interaction effect between Lithium and Lurasidone HCl.
详细描述
To compare the steady state pharmacokinetic profile of lurasidone 120 mg QD when administered alone vs. the steady state pharmacokinetic profile of lurasidone 120 mg QD when coadministered with steady state lithium 600 mg BID.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 否
入选标准
- •Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform.
- •Females who participate in this study:
- •are unable to have children-OR-
- •are willing to remain abstinent from Day -5 until 90 days after discharge;
- •Males must be willing to remain sexually abstinent or use an effective method of birth control (e.g. condom) from Day -5 until 90 days after discharge.
- •Able and agree to remain off of prior antipsychotic medication for the duration of the study.
排除标准
- •Presence or history (within the last year) of a medical or surgical condition (e.g. gastrointestinal disease) that might interfere with the absorption, metabolism, or excretion of orally administered lurasidone.
- •Positive test results within 30 days prior to the start of the study for:
- •Participated in another clinical trial or receiving an investigational product within 30 days prior to drug administration.
- •Use of concomitant medications that prolong the QT/QTc interval within 14 days prior to Day - 5 to follow-up
- •Use of a monoamine oxidase inhibitor within 21 days prior to Day 1 to Restabilization.
- •Received depot neuroleptics unless the last injection was at least 1 treatment cycle before Day -5.
研究组 & 干预措施
Lithium/Lurasidone
Other
Schizophrenia Patients
干预措施: Lurasidone HCl (Drug)
研究者
研究点 (1)
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