A Randomized, Two-Way, Single-Dose, Open-Label Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Dexmethylphenidate Hydrochloride, (10 mg), Compared to and Equivalent Dose of a Commercially Available Reference Drug Product (Focalin®, Novartis Pharmaceuticals Corporation) in 24 Fasted, Healthy, Adult Subjects
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 randomized, single-dose, two-way evaluation is to compare the bioequivalence of a test dexmethylphenidate hydrochloride formulation to an equivalent oral dose of the commercially available dexmethylphenidate hydrochloride in a test population of 24 adult subjects under fasted conditions.
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 —（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
1
干预措施: Dexmethylphenidate Hydrochloride (Drug)
2
Focalin®
干预措施: Dexmethylphenidate Hydrochloride (Drug)
结局指标
主要结局
Cmax (Maximum Observed Concentration)
时间窗: Blood samples collected over a 16 hour period.
Bioequivalence based on Cmax.
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
时间窗: Blood samples collected over a 16 hour period.
Bioequivalence based on AUC0-t.
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
时间窗: Blood samples collected over a 16 hour period.
Bioequivalence based on AUC0-inf.
次要结局
未报告次要终点