Evaluate The Pharmacokinetics Of Two Alprazolam Formulations (Immediate Release And Extended Release Tablets) And A Clonazepam Tablet In A Healthy Mexican Population
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- AUC last: Area under the curve of plasma concentration from administration up to time t (last sampling timepoint) calculated by trapezoid method.
研究概览
简要总结
To estimate the pharmacokinetics of single doses of benzodiazepines in Mexican adult healthy volunteers: a) alprazolam tablet extended release, b) alprazolam tablet immediate release, and clonazepam tablet.
详细描述
To determine pharmacokinetics of alprazolam and clonazepam in Latin-American population; in Mexico, both drugs are still widely used as first or second choice in the treatment of anxiety disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female volunteers aged between 18 and 40 years old.
排除标准
- •Subjects presenting changes on their vital signs constants registered at volunteers' screening.
- •Volunteers with any of the following: noncompliance of proposed inclusion criteria; requiring another drug product throughout the study conduction; pregnant or nursing females; history of cardiovascular, renal, hepatic, muscular, metabolic, gastrointestinal, neurological, endocrine, psychiatric, hematopoietic or any other anemia kind, disease, asthma, or organic disorder; history of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer or any condition possibly affecting drug absorption; history of acute narrow or glaucoma; exposed to drug products known as hepatic enzyme or inductors; who had received any drug product within 14 days or 5 half lives; who had been hospitalized due to any problem within 60 days prior to study start; history of sensitivity to BZD; who had drink alcohol or any beverage containing xanthines or who had taken smoked food or grapefruit juice within 72 hours prior to start hospitalization period, who had blood donated or lost 450 mL or more within 60 days prior to study start; requiring any special diet regardless the cause.
研究组 & 干预措施
Treatment A
干预措施: Alprazolam (Drug)
Treatment B
干预措施: Alprazolam XR (Drug)
Treatment C
干预措施: Clonazepam (Drug)
结局指标
主要结局
AUC last: Area under the curve of plasma concentration from administration up to time t (last sampling timepoint) calculated by trapezoid method.
时间窗: Sampling times: 0 to 96 hours
Cmax: Maximum plasma concentration graphically obtained, based on plasma concentration versus time profile.
时间窗: Sampling times: 0 to 96 hours
AUC inf: Area under the curve of plasma concentration from administration up to infinitum extrapolated time.
时间窗: Sampling times: 0 to 96 hours
t 1/2: Half life time.
时间窗: Sampling times: 0 to 96 hours
Tmax: Time from administration up to maximum plasma concentration, graphically obtained based on plasma concentration versus time profile.
时间窗: Sampling times: 0 to 96 hours
次要结局
- No Secondary Outcomes