A Relative Bioavailability Study of 80 mg Pravastatin Sodium Tablets Under Non-Fasting Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Cmax - Maximum Observed Concentration - Pravastatin in Plasma
研究概览
简要总结
This study compared the relative bioavailability (rate and extent of absorption) of Pravastatin Sodium Tablets 80 mg by Teva Pharmaceutical Industries, Ltd. with that of Pravachol® Tablets 80 mg by Bristol-Myers Squibb Company following a single oral dose (1 x 80 mg tablet)in healthy adult male subjects administered under non-fasting conditions.
详细描述
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Outcome: Confidence interval fell within 80-125% therefore met the FDA Bioequivalence criteria; no drug related, serious, unexpected adverse events were reported during the study.
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
- 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
Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period
干预措施: Pravastatin (Drug)
Pravachol®
Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period
干预措施: Pravastatin (Drug)
结局指标
主要结局
Cmax - Maximum Observed Concentration - Pravastatin in Plasma
时间窗: Blood samples collected over 16 hour period
Bioequivalence based on Cmax
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 16 hour period
Bioequivalence based on AUC0-t
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
时间窗: Blood samples collected over 16 hour period
Bioequivalence based on AUC0-inf
次要结局
未报告次要终点