NCT00649467已完成1 期
Single-Dose Fasting Bioequivalence Study of Topiramate Sprinkle Capsules (25 mg; Mylan) and Topamax® Sprinkle Capsules (25 mg; Ortho-McNeil Neurologics) in Healthy Volunteers Dosed With Applesauce
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
研究概览
简要总结
The objective of this study was to investigate the bioequivalence of Mylan's topiramate sprinkle 25 mg capsule to Ortho-McNeil's Topamax® Sprinkle 25 mg capsule following a single, oral 25 mg (1 x 25 mg) dose sprinkled on one teaspoon of applesauce 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
- 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
- •healthy, adult subjects, 18 years and older
- •able to swallow medication
排除标准
- •institutionalized subjects
- •history of any significant disease
- •use of any prescription or OTC medications within 14 days of start of study
- •received any investigational products within 30 days prior to start of study
研究组 & 干预措施
1
Experimental
Topiramate Sprinkle Capsules 25 mg
干预措施: Topiramate Sprinkle Capsules 25 mg (Drug)
2
Active Comparator
Topamax® Sprinkle Capsules 25 mg
干预措施: Topamax® Sprinkle Capsules 25 mg (Drug)
结局指标
主要结局
The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
时间窗: blood collections through 144 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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