NCT04969211已完成1 期
An Open-Label, Two-Period, Randomized, Single Oral Dose, Crossover Study to Evaluate the Bioequivalence of VHX-896 Tablets Relative to Iloperidone Tablets in Healthy Volunteers
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
- 25
- 试验地点
- 1
- 主要终点
- Assessment of Safety and Tolerability of a single dose of VHX-896
研究概览
简要总结
This is a single center, two-period, randomized study to evaluate the Bioequivalence of VHX-896 Tablets Relative to Iloperidone Tablets in Healthy Volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and/or female participants between 18 to 55 years (inclusive).
- •Have a Body Mass Index (BMI) of > 18.0 and < 30.0 kg/m2; (BMI = weight (kg)/ [height (m)]2).
- •Good health as determined by no clinically significant deviations from normal in medical history, clinical laboratory determination, ECGs, and physical examinations conducted during the screening visit.
- •Participants with no clinically significant medical, psychiatric or sleep disorders as determined by the PI.
排除标准
- •Participants with history of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
- •Participants who suffered from significant physical illness (required hospitalization) in the 4-week period preceding baseline will be excluded.
- •Pregnant or nursing (lactating) women.
研究组 & 干预措施
Sequence A: VHX-896 then iloperidone
Experimental
干预措施: VHX-896 and iloperidone (Drug)
Sequence B: Iloperidone then VHX-896
Experimental
干预措施: Iloperidone and VHX-896 (Drug)
结局指标
主要结局
Assessment of Safety and Tolerability of a single dose of VHX-896
时间窗: 17 days
As measured by the incidence of adverse events and clinically significant changes in laboratory values, ECG parameters, and vital signs
Bioequivalence between VHX-896 tablets relative to iloperidone tablets
时间窗: 96 hours
as measured by plasma concentrations
次要结局
未报告次要终点
研究者
研究点 (1)
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