NCT00674310已完成不适用
A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Under Fed Conditions
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 主要终点
- Bioequivalence
研究概览
简要总结
The objective of this study was to assess the single dose bioequivalence of Roxane's Ropinirole tablets,0.25 mg, to ReQuip Tablets, 0.25 mg (GlaxoSmithKline) under fed conditions using a single dose, randomized, 2-treatment, 2-period, 2-sequence cross-over design.
详细描述
The objective of this study was to assess the single dose bioequivalence of Roxane's Ropinirole tablets,0.25 mg, to ReQuip Tablets, 0.25 mg (GlaxoSmithKline) under fed conditions using a single dose, randomized, 2-treatment, 2-period, 2-sequence cross-over design.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No clinically significant abnormal finding on the physical examination, medical history, or clinical laboratory results during screening
排除标准
- •Positive test for HIV, Hepatitis B, or Hepatitis C.
- •Treatment with known enzyme altering drugs.
- •History of allergic or adverse response to ropinirole or any other comparable product.
结局指标
主要结局
Bioequivalence
时间窗: Baseline, Two period, seven day washout
次要结局
未报告次要终点
研究者
相似试验
已完成
不适用
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Und Fasted ConditionsRestless Leg SyndromeParkinson's DiseaseNCT00673088Roxane Laboratories30
已完成
不适用
Bioequivalency Study of 5 mg Pilocarpine Tablets Under Fasting ConditionsDry MouthNCT00601874Roxane Laboratories28
已完成
不适用
Bioequivalency Study of 5 mg Piolocarpine Tablets Under Fed ConditionsDry MouthNCT00601211Roxane Laboratories28
已完成
不适用
Bioequivalency Study of 7.5 mg Pilocarpine Under Fed ConditionsDry MouthNCT00618059Roxane Laboratories28
已完成
不适用
Bioequivalency Study of 7.5 mg Pilocarpine Tablets Under Fasting ConditionsDry MouthNCT00602524Roxane Laboratories28