NCT00881179已完成1 期
A Relative Bioavailability of Clarithromycin 250 mg Tablets 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
To demonstrate the relative bioavailability of Cilostazol 50 mg tablets under 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 59 Years（Adult）
- 性别
- All
- 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
Clarithromycin 250 mg Tablets (Geneva Pharmaceuticals, USA)
干预措施: Clarithromycin 250 mg Tablets (Geneva Pharmaceuticals, USA) (Drug)
2
Active Comparator
Biaxin (Clarithromycin) 250 mg Tablets (Abbott Laboratories, Inc, USA)
干预措施: Biaxin (Clarithromycin) 250 mg Tablets (Abbott Laboratories, Inc, USA) (Drug)
结局指标
主要结局
Bioequivalence based on AUC and Cmax
时间窗: 9 days
次要结局
未报告次要终点
研究者
相似试验
已完成
1 期
To Demonstrate the Relative Bioavailability of Clarithromycin 250 mg Tablets Under Fasting ConditionsHealthyNCT00881738Sandoz32
已完成
1 期
To Demonstrate the Relative Bioavailability of Cilostazol 50 mg Tablets Under Fasting ConditionsPainNCT00881231Sandoz26
已完成
不适用
Bioequivalence Study of Clarithromycin 500mg Tablets Under Fasting Conditions.HealthyNCT00774644Ranbaxy Laboratories Limited33
已完成
不适用
Bioequivalence Study of Clarithromycin 500 mg Tablets Under Non-Fasting ConditionsHealthyNCT00774696Ranbaxy Laboratories Limited24
已完成
1 期
Fasted Bioavailability Study of Cilostazol Tablets, 50mgTherapeutic Equivalency, HealthyNCT00685802Mutual Pharmaceutical Company, Inc.32