Randomized, 2-Way Crossover, Bioequivalence Study of Valacyclovir 1000 mg Tablet and Valtrex Administered as 1 x 1000 mg Tablet in Healthy Subjects Under Fed Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) - Valacyclovir
研究概览
简要总结
The objective of this study was to compare the rate and extent of absorption of Teva Pharmaceuticals USA valacyclovir and GlaxoSmithKline, USA (Valtrex) valacyclovir, administered as 1 x 1000 mg tablet under fed 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Valacyclovir
Test 1000 mg Tablet
干预措施: Valacyclovir (Drug)
Valtrex
Reference Listed Valacyclovir 1000 mg Tablet
干预措施: Valacyclovir (Drug)
结局指标
主要结局
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) - Valacyclovir
时间窗: Blood samples collected over 12 hour period
Bioequivalence based on AUC0-inf
Cmax (Maximum Observed Concentration of Drug Substance in Plasma) - Valacyclovir
时间窗: Blood samples collected over 12 hour period
Bioequivalence based on Cmax
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) - Valacyclovir
时间窗: Blood samples collected over 12 hour period
Bioequivalence based on AUC0-t
次要结局
- AUC0-t (Area Under Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) - Acyclovir(Blood samples collected over 24 hour period)
- Cmax (Maximum Observed Concentration of Drug Substance in Plasma) - Acyclovir(Blood samples collected over 24 hour period)
- AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) - Acyclovir(Blood samples collected over 24 hour period)