A Relative Bioavailability Food Challenge Study of Pravastatin Sodium 40 mg Tablets
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cmax - Maximum Observed Concentration
研究概览
简要总结
The objective of this study is to compare the relative bioavailability of pravastatin 40 mg tablets with that of Pravachol 40 mg tablets in healthy adult male subjects under non-fasting conditions. A second objective is to compare the difference in plasma levels after dosing the test formulation with and without food.
详细描述
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
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 45 Years（Adult）
- 性别
- Male
- 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
Pravastatin fast
Test product under fasting conditions dosed in first period followed by either test or reference product dosed under fed conditions in second and third periods
干预措施: pravastatin (Drug)
Pravastatin
Test product under fed conditions dosed in first period followed by either test product dosed under fasting conditions or reference product dosed under fed conditions in second and third periods
干预措施: pravastatin (Drug)
Pravachol®
Reference product under fed conditions dosed in first period followed by test product dosed under either fed or fasted conditions in second and third periods
干预措施: Pravachol® (Drug)
结局指标
主要结局
Cmax - Maximum Observed Concentration
时间窗: Blood samples collected over 24 hour period
AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)
时间窗: Blood samples collected over 24 hour period
AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)
时间窗: Blood samples collected over 24 hour period
次要结局
- Cmax - Comparison of the difference in plasma levels after dosing with test product under fasted and fed conditions(Blood samples collected over 24 hour period)
- AUC0-inf - Comparison of the difference in plasma levels after dosing with test product under fasted and fed conditions(Blood samples collected over 24 hour period)
- AUC0-t - Comparison of the difference in plasma levels after dosing with test product under fasted and fed conditions(Blood samples collected over 24 hour period)