临床试验/NCT01105208

NCT01105208已完成1 期

Prospective, Randomized, Open Label, Crossover Study to Compare the Bioavailability Between Optocef From Bayer (Cephalexin Suspension 250 mg/5 mL and Equivalent Concentration of Keflex Pediatrico From Eli Lilly (Cephalexin Suspension 125 mg/5mL) in Healthy Subjects Under Fasting Conditions

Bayer0 个研究点目标入组 26 人开始时间: 2010年3月最近更新: 2014年5月20日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Bayer
入组人数: 26
主要终点: Least square estimator of average maximum plasmatic concentration (log transformed)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

A single dose, two treatments (two cephalexin suspension brands), two sequences, cross-over design was used with a washout of 7 days between the two study periods. Treatment groups balanced with the same number of healthy volunteers who were randomly (in two strata: male and female) assigned to the study drug administration sequences

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy male or female volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis

排除标准

•History of illnesses or any organic abnormalities that could affect the results of the study
•History of abuse tobacco or alcohol or regular use of recreational or therapeutic drugs
•Subjects that have taken any medication within 14 days or that are in an elimination period of less than 7 half-lives (whichever is longest) before study startup.

研究组 & 干预措施

Arm 1

Experimental

干预措施: Cephalexin suspension (Optocef, BAYO5448 ) (Drug)

Arm 2

Active Comparator

干预措施: Cephalexin suspension (Keflex) (Drug)

结局指标

主要结局

Least square estimator of average maximum plasmatic concentration (log transformed)

时间窗: After two months

Least square estimator of area under the pharmacokinetic curve (log transformed)

时间窗: After two months

次要结局

Half life of plasmatic concentration of study drug(After two months)
Adverse events collection(Up to 6 weeks)
Clearance constant of plasmatic concentrations of study drug(After two months)
Time at which maximum concentration is reached(After two months)
Area under the pharmacokinetic curve from time=0 to last blood sample(After two months)

研究者

发起方

Bayer

申办方类型

Industry

责任方

Sponsor

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