NCT00865085已完成1 期
Single Dose Crossover Comparative Bioavailability Study of Citalopram 40 mg Tablets in Healthy Male Volunteers/Fasting State
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Actavis Inc.
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Rate and Extend of Absorption
研究概览
简要总结
The purpose of this study is to evaluate and compare the relative bioavailability, and therefore the bioequivalence of two formulations of Citalopram after a single dose administration under fasting conditions.
详细描述
Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.
Official Title: Single Dose Crossover Comparative Bioavailability Study of Citalopram 40 mg Tablets in Healthy Male Volunteers/Fasting State
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form duly signed by the subject.
- •Males aged from 18 to 50 years with a body mass index (8MI) within 19-30; demographic data (sex, age, ethnic group, body weight, height and smoking habits) will be recorded and reported in the final report.
- •Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance and must be recorded as such in the CRF.
- •Healthy according to the laboratory results and physical examination
- •Normal cardiovascular function according to ECG.
- •Subjects should be non- or ex-smokers.
排除标准
- •Significant history of hypersensitivity to citalopram or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs.
- •Presence or history of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
- •Presence or history of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease.
- •Use of MAO inhibitors within 14 days of day 1 of the study
- •Maintenance therapy with any drug, or significant history of drug dependency, alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic), or serious Psychological disease.
- •Any clinically significant illness in the previous 28 days before day 1 of this study.
- •Use of enzyme-modifying drugs in the previous 28 days before day 1 of this study (all barbiturates, corticosteroids, phenylhydantoins, etc.).
- •Participation in another clinical trial in the previous 28 days before day 1 of this study.
- •Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study.
- •Positive urine screening of drugs of abuse.
- •Positive results to HIV, HBsAg or anti-HCV tests
- •History of fainting upon blood sampling
研究组 & 干预措施
B
Active Comparator
CelexaTM 40 mg tablets, single dose
干预措施: CelexaTM 40 mg tablets, single dose (Drug)
A
Experimental
Citalopram HBr 40 mg tablets, single dose
干预措施: Citalopram HBr 40 mg tablets, single dose (Drug)
结局指标
主要结局
Rate and Extend of Absorption
时间窗: 168 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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