NCT01082276已完成1 期
Rifampin 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
- 20
- 试验地点
- 1
研究概览
简要总结
The effect of rifampin on the pharmacokinetics of lurasidone
详细描述
by performing an open-label, 2-period, sequential study in healthy subjects. All subjects (N=20) will be assigned to the same treatment sequence, 40 mg po dosing.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Female subjects must be of nonchildbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or post-menopausal ≥ 1 year) with follicle stimulating hormone [FSH] > 40 U/L).
- •Subjects with partners of child-bearing potential must agree to use barrier contraception during the study and for 90 days after discharge. Volunteers must agree to not donate sperm during the study and for 90 days after discharge.
排除标准
- •Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
- •Use of concomitant medications that prolong the QT/QTc interval from 14 days prior to day - 2 to discharge.
- •Use of any inhibitor or inducer of CYP3A4 taken within 30 days prior to study Day -2
- •Use of (an) investigational drug(s) within the 30 days or 5 half-lives (whichever was longer) prior to Screening.
- •Previous exposure to lurasidone (SM-13496).
研究组 & 干预措施
Rifampin/Lurasidone
Other
Healthy Normal Subject
干预措施: Lurasidone HCl (Drug)
研究者
研究点 (1)
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