A pilot study to test and validate the applicability of a bio-analytical assay for betahistine in plasma obtained from healthy male subjects after administration of a single dose of the marketed betahistine 24 mg IR tablet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Cmax, tmax, λz, t1/2, AUC0-t and AUC for both betahistine and metabolite 2-Pyridyl Acetic Acid ;
研究概览
简要总结
The aim of the study is to generate plasma samples after single-dose oral administration of betahistine to test and validate a new sensitive bio-analytical assay method measuring betahistine and 2-pyridyleacetic acid (2-PAA) in human plasma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Male
入选标准
- 未提供
排除标准
- •Subjects who participated in a previous betahistine trial •Subjects who can not communicate reliable with the investigator •Subjects who are unlikely to co-operate with the requirements of the study.
结局指标
主要结局
Cmax, tmax, λz, t1/2, AUC0-t and AUC for both betahistine and metabolite 2-Pyridyl Acetic Acid ;
时间窗: Blood samples for plasma betahistine / 2-PAA PK profiles will be taken on Day 1 / 2 (pre-dose, 0.050, 0.083, 0.167, 0.250, 0.333, 0.416, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 3.000, 4.000, 6.000, 8.000, 10.000, 12.000, 15.000, 18.000 and 24.000 hours post-dose).
CL/F and Vz/F for betahistine only
时间窗: Blood samples for plasma betahistine / 2-PAA PK profiles will be taken on Day 1 / 2 (pre-dose, 0.050, 0.083, 0.167, 0.250, 0.333, 0.416, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 3.000, 4.000, 6.000, 8.000, 10.000, 12.000, 15.000, 18.000 and 24.000 hours post-dose).
次要结局
- adverse event and concomitant medication recording.(Blood samples for plasma betahistine / 2-PAA PK profiles will be taken on Day 1 / 2 (pre-dose, 0.050, 0.083, 0.167, 0.250, 0.333, 0.416, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 3.000, 4.000, 6.000, 8.000, 10.000, 12.000, 15.000, 18.000 and 24.000 hours post-dose).)
- Safety assessments including medical and drug history, physical examination, vital signs, 12-lead ECG, safety laboratory tests,(viral serology, urine drug screen / alcohol breath test)