NCT04145570已完成4 期
A Single-Dose,ComparativeBioavailability Study ofTwo Formulations ofErlotinib150mgTabletsunderFastingConditions
Quadras Scientific Solutions0 个研究点目标入组 24 人开始时间: 2008年10月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 主要终点
- Bioequivalence (Biodisponibility)
研究概览
简要总结
Theobjectiveofthisstudyistoevaluatethecomparativebioavailabilitybetween:
- ErlotinibHCl150mgTablets(Novopharm Limited,Canada)and
- Tarceva® 150mgTablets(Hoffmann-LaRocheLimited,Canada) afterasingle-doseinhealthysubjectsunderfastingconditions.
详细描述
This is a blinded,single-dose,randomized,two-period,two-sequence,two-treatment,cross over study, designed to evaluate the comparative bioavailability of two formulations of erlotinib HCl 150mg tablets administered to healthy male and female subjects under fasting conditions.
• SubjectswererandomlyassignedtooneofthetwodosingsequencesABorBA underfasting conditions.
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, non-smoking, post-menopausal and/or surgically sterile female subjects
- •Healthy,non-smoking male subjects. Allsubjects willbe from 18 to 55 years ofage.
排除标准
- •Known history or presence of any clinically significant medicalcondition.
- •Known or suspected carcinoma.
- •Presence ofclinically significant gastrointestinal disease or history of malabsorption within the last year.
- •Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption.
- •Use of tobacco or nicotine-containing products within 6 months priorto drug administration.
研究组 & 干预措施
Erlotinib HCl 150 mg
Experimental
Crossover
干预措施: Erlotinib HCl 150 mg (Drug)
Tarceva® 150 mg
Active Comparator
Crossover
干预措施: Tarceva® (Drug)
结局指标
主要结局
Bioequivalence (Biodisponibility)
时间窗: 72 hours
Compared Bioequivalence
次要结局
未报告次要终点
研究者
Gastón Kuperman
Doctor Clinical - Head of R&D
Quadras Scientific Solutions
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