NCT01082263已完成1 期
Midazolam Drug-Drug Interaction Study With Lurasidone HCl
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
A Phase I, Drug-Drug Interaction Study between Midazolam and Lurasidone HCl.
详细描述
lurasidone 120 mg, midazolam 5 mg
To compare the single-dose pharmacokinetic profile of midazolam 5 mg when administered alone vs. when administered with a single-dose of lurasidone 120 mg.
To compare the single dose pharmacokinetic profile of midazolam 5 mg when administered alone vs. when administered after steady state dosing with lurasidone 120 mg.
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 disorders
- •Females who participate in this study:
- •are unable to have children -OR- are willing to remain abstinent from Day -5 to 90 days after discharge; -OR- are willing to use an effective method of double-barrier birth control from Day -5 to 90 days after discharge.
- •Males must be willing to remain sexually abstinent or use an effective method of birth control from Day -5 to 90 days after discharge.
- •Able and agree to remain off of prior antipsychotic medication for the duration of the study.
排除标准
- •Known presence or history of renal or hepatic insufficiency.
- •A history or presence of abnormal electrocardiogram (ECG
- •Known history or presence of clinically significant intolerance to antipsychotic medications.
- •Significant orthostatic hypotension (i.e. a drop in systolic blood pressure of 30 mmHg or more and/or drop in diastolic blood pressure of 20 mmHg or more on standing).
- •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.
- •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 including but not limited to those listed in Appendix 19.
- •Received depot neuroleptics unless the last injection was at least 1 treatment cycle before Day -
- •Difficulty fasting or consuming the FDA high fat meals.
- •At risk with midazolam dosing with respiratory disease or impaired gag reflex, in the opinion of the investigator.
研究组 & 干预措施
Midazolam/Lurasidone
Other
Schizophrenia patient
干预措施: Lurasidone HCl (Drug)
研究者
研究点 (1)
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