A Relative Bioavailability Study of Bupropion Extended-Released 150 mg Tablets Under Fasting Conditions
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT00865410
- Lead Sponsor
- Actavis Inc.
- Brief Summary
The purpose of this study is to compare the rate and extent of absorption of Bupropion HCl extended-release tablet (test) to that of Wellbutrin SR extended-release tablet (reference) after a single, one-tablet (150 mg) dose in fasted subjects.
- Detailed Description
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 Fasted, Normal, Healthy Subjects.
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description A Abrika Bupropion 150 mg Extended-Released Tablet Abrika Bupropion 150 mg Extended-Released Tablet, single dose B Wellbutrin SR® 150 mg Extended-Release Tablet, single dose Wellbutrin SR® 150 mg Extended-Release Tablet, single dose
- Primary Outcome Measures
Name Time Method Rate and Extend of Absorption 120 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
SFBC Ft. Myers, Inc.
🇺🇸Ft. Myers, Florida, United States