A Randomized, Single Dose Two -Way Crossover Relative Bioavailability Study of Bupropion Extended-Released Tablets Formulation in Normal, Healthy Man Following a Standard Meal
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Actavis Inc.
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Rate and Extend of Absorption
研究概览
简要总结
The purpose of this study is to compare the rate and extent of absorption of Abrika Bupropion 150 mg Extended-Release Tablet to that of Wellbutrin SR® 150 mg Tablet after a single, one-tablet dose in subjects fed a standard meal.
详细描述
Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.
Official Title: A Randomized, Single Dose Two -Way Crossover Relative Bioavailability Study of Bupropion Extended-Released Tablets Formulation in Normal, Healthy Man Following a Standard Meal
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Is the individual a healthy, normal adult man who volunteers to participate?
- •Is he 18-45 years of age, inclusive?
- •Is his BMI ≤30?
- •Is he considered reliable and capable of understanding his responsibility and role in the study?
- •Has he provided written informed consent? A no answer to any of the above questions indicates that the individual is ineligible for enrollment
排除标准
- •Does the individual have a history of allergy or hypersensitivity to bupropion, milk or eggs?
- •Does he smoke more than 25 cigarettes/day?
- •Is he unable to refrain from smoking during the period beginning two hours before and ending four hours after study drug administration?
- •Does he have a history of seizure, cranial trauma, or other predisposition to seizure?
- •Does he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his safety?
- •Does he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, renal or other diseases, conditions or surgeries that would interfere with the conduct or interpretation of the study or jeopardize his safety?
- •Does he have serious psychological illness?
- •Does he have significant history (within the past six months) or clinical evidence of alcohol or drug abuse?
- •Does he have a positive urine drug screen or saliva alcohol screen, or a positive HIV-l, or hepatitis B or C screen?
- •Is he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 24 and 48 hours, respectively, prior to study drug administration and ending when the last blood sample has been taken?
- •Has he used any prescription drug during the 14-day period prior to study initiation (except for topical products without systemic absorption), or any OTC drug during the 72-hour period preceding study initiation?
- •Is he unable to refrain from the use of all concomitant medications during the study?
- •Has he donated or lost blood, or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six week period preceding study initiation?
- •Has he donated plasma during the two week period preceding study initiation?
- •Has he received an investigational drug during the 30 day period preceding study initiation? A yes answer to any of the above questions indicates that the individual is ineligible for enrollment
研究组 & 干预措施
A
Abrika Bupropion 150 mg Extended-Released Tablet, single dose
干预措施: Abrika Bupropion 150 mg Extended-Released Tablet (Drug)
B
Wellbutrin SR® 150 mg Extended-Release Tablet, single dose
干预措施: Wellbutrin SR® 150 mg Extended-Release Tablet, single dose (Drug)
结局指标
主要结局
Rate and Extend of Absorption
时间窗: 120 hours
次要结局
未报告次要终点