NCT00992238已完成1 期
A Relative Bioavailability Study of 100 mg Flavoxate Hydrochloride Tablets Under 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
- Padagis LLC
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Bioequivalence according to US FDA guidelines
研究概览
简要总结
The purpose of this study is to compare the relative bioavailability of Flavoxate Hydrochloride tablets 100mg manufactured by Paddock Laboratories, Inc., with that of Urispas® tablets 100mg by SmithKline Beecham Pharmaceuticals 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good health as determined by lack of clinically significant abnormalities in health assessment performed at screening
排除标准
- •Positive test results for HIV or Hepatitis B or C
- •History of allergy or sensitivity to Flavoxate hydrochloride or related drugs
研究组 & 干预措施
Flavoxate Hydrochloride Tablets, 100mg
Experimental
干预措施: Flavoxate Hydrochloride Tablets, 100mg (Drug)
Urispas® Tablets, 100mg
Active Comparator
干预措施: Urispas® Tablets, 100mg (Drug)
结局指标
主要结局
Bioequivalence according to US FDA guidelines
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
90 mg Fluoxetine Hydrochloride Capsules Under Fasting ConditionsHealthyNCT01247272Teva Pharmaceuticals USA26
已完成
1 期
90 mg Fluoxetine Hydrochloride Capsules Under Non-Fasting ConditionsHealthyNCT01247285Teva Pharmaceuticals USA26
已完成
1 期
Fexofenadine Hydrochloride 180 mg Tablets Under Fasting ConditionsHealthyNCT00835276Teva Pharmaceuticals USA60
已完成
1 期
Fexofenadine Hydrochloride 180 mg Tablets Under Non-Fasting ConditionsHealthyNCT00835640Teva Pharmaceuticals USA24
已完成
1 期
To Demonstrate the Relative Bioavailability of Fluoxetine Hydrochloride Capsules, 40 mgDepressionNCT00947076Sandoz30