NCT00959933已完成1 期
A Relative Bioavailability Study of Ribavirin (Geneva Pharmaceutical Technology Corporation, N.J., U.S.A.) 200 Capsules and Rebetol (Schering Corporation, N.J., U.S.A.) 200 mg Capsules in Females Under Non-Fasting Conditions.
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
- Sandoz
- 入组人数
- 24
- 主要终点
- Bioequivalence based on AUC and Cmax
研究概览
简要总结
The purpose of this study is to demonstrate the relative bioavailability of Ribavirin 200 capsules and Rebetol 200 mg capsules in females under non-fasting conditions.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
排除标准
- •Positive test results for HIV or hepatitis B or C.
- •Treatment for drug or alcohol dependence.
研究组 & 干预措施
1
Experimental
Ribavirin 200 Capsules (Geneva Pharmaceutical, U.S.A.)
干预措施: Ribavirin 200 Capsules (Geneva Pharmaceutical, U.S.A.) (Drug)
2
Active Comparator
Rebetol 200 Capsules (Schering Corporation, U.S.A.)
干预措施: Rebetol 200 Capsules (Schering Corporation, U.S.A.) (Drug)
结局指标
主要结局
Bioequivalence based on AUC and Cmax
时间窗: 30 days
次要结局
未报告次要终点
研究者
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