A Phase 1 Crossover Study of Blood Pressure and Heart Rate Response to Pseudoephedrine Concurrent With Placebo or TR 701 FA
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Systolic Blood Pressure
研究概览
简要总结
This is a randomized, double-blinded, placebo-controlled, crossover study to evaluate the pressor effects of pseudoephedrine when administered with TR-701 FA in healthy adult volunteers.
详细描述
Eligible subjects will be randomized to 1 of 2 possible treatment sequences (N=9 per sequence) on Study Day 1. Subjects will receive oral 200 mg TR 701 FA or Placebo for TR 701 FA once daily for 5 days during each treatment period, with a 2 day washout between periods (72 hours between doses). On Study Day 5 of each treatment period, subjects will also receive oral 60 mg PSE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects between 18 and 45 years of age, inclusive
- •Healthy males and females with no clinically significant abnormalities identified by a detailed medical history
- •Body mass index ≥ 19.0 kg/m2 and ≤ 31.0 kg/m2
排除标准
- •Systolic blood pressure > 130 mmHg or < 90 mmHg measured after 10 minutes supine at the Screening Visit and Study Day 1
- •Diastolic blood pressure > 90 mmHg or < 60 mmHg measured after 10 minutes supine at the Screening Visit and Study Day 1
- •Heart rate > 90 bpm or < 50 bpm measured after 10 minutes supine at the Screening Visit and Study Day
- •Known allergy or hypersensitivity to PSE
研究组 & 干预措施
TR-701 FA with PSE
TR-701 FA 200 mg oral with PSE
干预措施: TR-701 FA with PSE (Drug)
TR-701 FA Placebo with PSE
TR-701 FA Placebo 200 mg oral with PSE
干预措施: TR-701 FA Placebo with PSE (Other)
结局指标
主要结局
Systolic Blood Pressure
时间窗: 13 days
To compare systolic blood pressure post administration of pseudoepherine concurrent with TR-701 FA and Placebo
次要结局
未报告次要终点