NCT01777685已完成不适用
Therapeutic Drug Monitoring and Pharmacokinetic Compartmental Analysis of Sulpiride
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- •Assessment of the bioequivalence of the oral suspension formulation, the oral solution formulation, and the marketed tablet formulation of levofloxacin, on Days 1, 2, and 3, using the marketed tablet as the reference. Pharmacokinetics of sulpiride
研究概览
简要总结
The present study was adopted to evaluate the pharmacokinetics of sulpiride after oral administration.
详细描述
The present study was adopted to evaluate the pharmacokinetics of sulpiride after administration of single oral doses of 50 mg in an open-label, one-way study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •At least 18 years old and not more than 45 healthy male volunteers
- •Actual weight no more than ± 30% from ideal body weight based on sex, height, and body frame
- •Who had passed all the screening parameters
- •Free of any drug exposure known to interfere with the pharmacokinetics or assay of sulpiride for at least 10 days prior to the study
- •Who had to be able to communicate effectively with study personnel, be literate, and able to give consent.
排除标准
- •A clinically significant abnormal physical exam, medical history, or laboratory studies If they showed a sitting SBP of >140 or <100 mmHg, DBP > 90 or <60mm Hg, or a pulse rate of > 95 or < 50 beats/min at screening A history of serious intolerance, allergy, or sensitivity to fexofenadine The use of any prescription drug within the previous month or use of any over-the-counter medication (with the exception of acetaminophen) within the past 14 days A history of blood dyscrasias A history of alcohol or drug abuse within the past year Donation of blood during the 8 weeks prior to the study or plans to donate blood during or within 8 weeks of completing the study Unable to tolerate vein puncture and multiple blood samplings Any surgical/medical condition that might alter drug absorption, distribution, metabolism, or excretion Cannot follow instructions, in the opinion of the investigator.
研究组 & 干预措施
sulpiride 50 mg
Other
干预措施: Sulpiride (Drug)
结局指标
主要结局
•Assessment of the bioequivalence of the oral suspension formulation, the oral solution formulation, and the marketed tablet formulation of levofloxacin, on Days 1, 2, and 3, using the marketed tablet as the reference. Pharmacokinetics of sulpiride
时间窗: The pharmacokinetic analysis is done after blood sampling
Assessment of the pharmacokinetics using compartmental and non compartmental analysis of sulpiride after oral administration
次要结局
未报告次要终点
研究者
研究点 (1)
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