NCT00538889已完成1 期
Combined Administration of Lecozotan SR and Citalopram: a Double Blind, Multiple Dose Study in Young Healthy Subjects
Wyeth is now a wholly owned subsidiary of Pfizer1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2007年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evaluation of 5-HT toxicity (Hunter serotonin toxicity criteria) and CNS questionnaires.
研究概览
简要总结
To assess the safety and tolerability of lecozotan SR and citalopram when coadministred to healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed and dated IRB/IEC-approved informed consent form before any study-specific screening procedures are performed.
- •Men or women aged 18 to 50 years, inclusive, at screening.
- •Women of nonchildbearing potential, defined as being surgically sterile or postmenopausal for > 1 year, may be included. For women below 50 years of age, at least two years of retrospective amenorrhea and FSH>38 and estrogen <20 are required.
- •Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight greater than or equal to 50 kg. BMI is calculated by taking the subject's weight, in kilograms, divided by the square of the subject's average height, in meters, at screening: BMI = weight (kg)/(height [m])2
排除标准
- •Presence or history of any disorder that may prevent the successful completion of the study.
- •Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead ECGs, or clinical laboratory test results.
- •Hypersensitivity to citalopram or any of the inactive ingredients in citalopram.
结局指标
主要结局
Evaluation of 5-HT toxicity (Hunter serotonin toxicity criteria) and CNS questionnaires.
次要结局
未报告次要终点
研究者
研究点 (1)
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