ACTRN12614000464662招募中1 期
A Single-Dose, Randomized, Open-Label, Crossover, Pilot, Comparative Bioavailability Study of Aprepitant 130 mg Injection (InnoPharma, Inc.), EMEND Registered Trademark 150 mg Injection (Merck Sharp & Dohme Corp.) and EMEND Registered Trademark 125 mg Capsules (Merck Sharp & Dohme Corp.) in Healthy Male and Female Volunteers under Fasting Conditions
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Healthy male and female; non-smoking; BMI that is within 18.5-29.9 kg/m^2, inclusive; Systolic blood pressure between 95-140 mmHg, inclusive, and diastolic blood pressure between 55-90 mmHg, inclusive, and heart rate between 50-100 bpm, inclusive; Ability to fast for at least 14 hours and consume standard meal; Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements.
排除标准
- •Individuals who have participated in another clinical trial or who received an investigational drug within 30 days prior to first drug administration; Consumption of food or beverages containing caffeine/methylxanthines, poppy seeds and/or alcohol within 48 hours before dosing and containing grapefruit and/or pomelo within 10 days prior to first drug administration; Use of any prescription medication within 14 days prior to first drug administration
研究者
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