NCT01122953已完成1 期
Bioequivalence Study Of 5ml Dose Of PHENYTOIN 125mg/ 5ml Suspension Made By Laboratorios Pfizer, S.A. De C.V. Versus EPAMIN® 125 mg/5ml Made By McNeil LA LLC, Study In Healthy Volunteers Under Fasting Conditions
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2010年4月最近更新:
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
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Area under the curve (AUC): The AUC from administration to the last sampling time will be determined by the trapezoid method.
研究概览
简要总结
To investigate the bioequivalence between two compounds (phenytoin and epamin) by a randomized, single dose study under fasting conditions in healthy volunteers.
详细描述
Bioequivalence study in healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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 and/or female subjects between the ages of 18 and 55 years
- •Body Mass Index (BMI) of 18 to 26.9 kg/m2 or ± 10% variation of the ideal weight; and a total body weight >50 kg (110 lbs).
- •An informed consent document signed and dated by the subject or a legally acceptable representative.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
- •A positive urine drug screen.
研究组 & 干预措施
Phenytoin
Experimental
干预措施: Phenytoin (Drug)
Epamin
Active Comparator
干预措施: Epamin (Drug)
结局指标
主要结局
Area under the curve (AUC): The AUC from administration to the last sampling time will be determined by the trapezoid method.
时间窗: 0-168 h
Maximum Concentration (Cmax): The maximum plasmatic concentration (Cmax) will be obtained as the highest concentration observed in the sampling interval.
时间窗: 0-168 h
Time maximum concentration (tmax) is observed. Will be reported as the time at which the maximum concentration is observed.
时间窗: 0-168 h
次要结局
- Constant of elimination (ke): Will be determined as the slope from the linear logarithmic regression of the terminal phase of the logarithmic graph of concentration over time.(0-168 h)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Bioequivalence Study Of Phenytoin Suspension Versus Epamin® In 34 Healthy Volunteers.HealthyNCT01122940Pfizer's Upjohn has merged with Mylan to form Viatris Inc.32
尚未招募
1 期
Bioequivalence of PhenytoiHealthy volunteersHealthy VolunteersRPCEC00000261Center for Pharmaceutical Research and Development, Havana, Cuba.24
招募中
Unknown
Bioequivalence study of Phenytoin 100 mg capsuleIRCT20210519051345N56Tabriz University of Medical Sciences24
已完成
1 期
Clinical Trial to Evaluate the Pharmacokinetic Characteristics of DW5221 and DW5221-RApetite StimulantsNCT06147908Daewon Pharmaceutical Co., Ltd.54
已完成
不适用
Comparative bioequivalency study (pharmacokinetics-pharmacodynamics) of Variopeptyl® 11.25 mg and Diphereline® 11.25 mg in Patients with non-metastatic or metastatic prostate cancer VolunteersIRCT20170225032759N3Varian Pharmed Co80