Bioequivalence and Clinical Effects of Generic and Brand Bupropion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Area Under the Curve (AUC0-24) Ratio for Racemic Bupropion
研究概览
简要总结
Determine bioequivalence between branded and generic bupropion extended release (XL) products (and between generic products) at steady state in patients with major depressive disorder.
详细描述
The protocol is a prospective, randomized, double-blinded, crossover study with Major Depressive Disorder (MDD) receiving bupropion HCl 300mg XL (branded or generic).
Subjects will be studied in 4 phases for a total of approximately 28 weeks:
Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
The randomization table will be generated by the Barnes-Jewish Hospital Investigational Pharmacy. Each subject will be assigned the next available number. Subjects, investigators, and all study team members will be blinded to drug treatment. In the case of dropouts (either subject- or investigator-initiated), subjects will be replaced, to provide the required number of subjects.
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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
StudyArm
Subjects will be studied for 28 weeks in a sequential cross-over study: a
Subjects will be studied in 4 phases for a total of approximately 28 weeks:
Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).
干预措施: Bupropion XL 300 (Drug)
结局指标
主要结局
Area Under the Curve (AUC0-24) Ratio for Racemic Bupropion
时间窗: For 24 hours approximately every 6 weeks
Area under the curve (AUC) generic/Area under the curve (AUC) brand bupropion
次要结局
未报告次要终点