NCT01615393已完成1 期
Prospective, Randomized, Single-blind, Cross-over, Comparative Study for Establishing Comparative Bioavailability of Copegus vs Vilona® in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Bioavailability
研究概览
简要总结
This prospective, randomized, single-blind, cross-over study will compare the bioavailability of Copegus (ribavirin) administered as tablets and ribavirin administered as capsules in healthy volunteers. Volunteers will be randomized to receive a single dose of 400 mg of ribavirin either as a capsule or as tablets; after a washout phase volunteers will be crossed-over to the other treatment. The anticipated time on study treatment is 10 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adult healthy volunteers, 18 to 55 years of age
- •Clinically healthy as confirmed by medical history, physical examination, electrocardiogram, thorax teleradiography and routine clinical laboratory measurements
- •Body mass index between 18 and 28 kg/m2
- •Negative testing for drugs of abuse
排除标准
- •History or presence of any clinically significant condition that might interfere with the pharmacokinetics of the study drugs
- •Volunteers require co-medications during the study
- •Exposure to agents known as inducers or inhibitors of hepatic enzymatic system within 30 days prior to study start
- •Having taken any medication with a clearance period of over seven half-life before study start
- •Hospitalization or significant illness 30 days before study start
- •Having received a investigational drug within 90 days prior to study start
研究组 & 干预措施
Ribavirin capsule arm
Active Comparator
干预措施: ribavirin [Vilona] (Drug)
Ribavirin tablet arm
Experimental
干预措施: ribavirin [Copegus] (Drug)
结局指标
主要结局
Bioavailability
时间窗: 10 days
次要结局
未报告次要终点
研究者
相似试验
已完成
1 期
A Study of Capecitabine Rapid Disintegrating Tablets (RDT) Versus Commercial Xeloda in Patients With Solid TumoursBreast Cancer, Colorectal CancerNCT01493336Hoffmann-La Roche37
已完成
1 期
Absolute Oral Bioavailability of RemimazolamBioavailabilityNCT04113564Paion UK Ltd.14
已完成
1 期
Telmisartan and Amlodipine Versus Monocomponent TabletsHypertensionNCT01278797Boehringer Ingelheim28
已完成
1 期
A Crossover Study to Evaluate Relative Bioavailability of Two JNJ-54781532 Tablet Formulations in Healthy Adult ParticipantsHealthyNCT02117505Janssen Research & Development, LLC20
已完成
1 期
Study to Evaluate Bioavailability of a Single 12 mg Dose of Perampanel for Three Intravenous Infusion Durations Relative to a Single 12 mg Perampanel Oral Tablet in Healthy SubjectsHealthy ParticipantsNCT03376997Eisai Inc.48