NCT00864981已完成1 期
A Relative Bioavailability Study of Bupropion HCI 150 mg Sustained-Release 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
- Sandoz
- 入组人数
- 32
- 主要终点
- Bioequivalence according to US FDA timelines
研究概览
简要总结
The purpose of this study is to demonstrate the relative bioequivalence of Bupropion HCI 150 mg SR 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 —（Adult, Older 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
Bupropion HCI ER Tablets, 150 mg
干预措施: Bupropion HCI ER Tablets, 150 mg; EON Labs Inc. (Drug)
2
Active Comparator
WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg
干预措施: WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg; GlaxoSmithKline (Drug)
结局指标
主要结局
Bioequivalence according to US FDA timelines
时间窗: 29 days
次要结局
未报告次要终点
研究者
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