NCT00460785已完成1 期
Phase 1 Single Center Trial to Demonstrate the Bioequivalence of a New Combination Analgesic Formulation as Compared to an Equimolar Marketed Formulation
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Bioequivalence acceptance range of 90CI of T/R ratios of AUC and Cmax.
研究概览
简要总结
The purpose of this study is to demonstrate bioequivalence of a new formulation to a reference
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Standard Phase I
- •Cyp 2D6 extensive metabolizers
排除标准
- •Standard Phase I
- •Contraindications of current reference tablet SmPC
结局指标
主要结局
Bioequivalence acceptance range of 90CI of T/R ratios of AUC and Cmax.
次要结局
- Descriptive, e. g. safety/tolerability of Test comparable to Reference
研究者
相似试验
已完成
1 期
Study to Assess Bioequivalence of a New Nifurtimox Oral Tablet FormulationBioequivalenceNCT03708133Bayer24
已完成
1 期
A Study to Assess Bioequivalence of Fezolinetant Formulations in Healthy Female ParticipantsHealthy VolunteersNCT04277624Astellas Pharma Global Development, Inc.22
已完成
1 期
Comparative Clinical Trial to Evaluate Bioequivalency and Safety of Monoclonal Antibody Injection and Adalimumab in Chinese Healthy VolunteersHealthyNCT02912247Innovent Biologics (Suzhou) Co. Ltd.183
已完成
早期 1 期
Comparative Bioavailability Study of TAH3311 5 mg Oral Dissolving Film vs ELIQUIS® 5 mg Tablet in Healthy VolunteersHealthy VolunteersFastingFedNCT05995119TAHO Pharmaceuticals Ltd.12
已完成
1 期
Bioequivalence And Food Effect Study Of Bosutinib In Healthy SubjectsPhiladelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML)NCT01374139Pfizer88