A Relative Bioavailability Study of Bupropion XL 150 mg Tablets Under Fed Conditions
This study has been completed.
Sponsor:
Actavis Inc.
Information provided by:
Actavis Inc.
ClinicalTrials.gov Identifier:
NCT00865462
First received: March 17, 2009
Last updated: August 13, 2010
Last verified: August 2010
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Purpose
The purpose of this study is to compare the rate and extent of absorption of Abrika Bupropion 150 mg XL Tablet to that of Wellbutrin XL® 150 mg Tablet after a single, one-tablet dose in subjects fed a standard meal.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Abrika Bupropion 150 mg XL Tablet, single dose Drug: Wellbutrin XL® 150 mg Tablet, single dose |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | A Randomized, Single Dose Two -Way Crossover Relative Bioavailability Study of Bupropion XL Tablets Formulation in Normal, Healthy Man Following a Standard Meal |
Resource links provided by NLM:
Further study details as provided by Actavis Inc.:
Primary Outcome Measures:
- Rate and Extend of Absorption [ Time Frame: 96 hours ] [ Designated as safety issue: No ]
| Enrollment: | 30 |
| Study Start Date: | July 2004 |
| Study Completion Date: | July 2004 |
| Primary Completion Date: | July 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Abrika Bupropion 150 mg XL Tablet, single dose
|
Drug: Abrika Bupropion 150 mg XL Tablet, single dose
A: Experimental Subjects received Abrika formulated products under fed conditions
Other Name: Bupropion
|
|
Active Comparator: B
Wellbutrin XL® 150 mg Tablet, single dose
|
Drug: Wellbutrin XL® 150 mg Tablet, single dose
B: Active comparator Subjects received GlaxoSmithKline formulated products under fed conditions
Other Name: Bupropion
|
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 XL 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
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Meena Venugopal, Director, Clinical R&D, Actavis Inc |
| ClinicalTrials.gov Identifier: | NCT00865462 History of Changes |
| Other Study ID Numbers: | 04-0646-004 |
| Study First Received: | March 17, 2009 |
| Last Updated: | August 13, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Actavis Inc.:
|
Bioequivalence Bupropion Healthy subjects |
Additional relevant MeSH terms:
|
Bupropion Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013