A Relative Bioavailability Study of Bupropion Extended-Released 150 mg Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Actavis Inc.
ClinicalTrials.gov Identifier:
NCT00865410
First received: March 17, 2009
Last updated: August 13, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Abrika Bupropion 150 mg Extended-Released Tablet
Drug: Wellbutrin SR® 150 mg Extended-Release 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 Extended-Released Tablets Formulation in Fasted, Normal, Healthy Subjects.

Resource links provided by NLM:


Further study details as provided by Actavis Inc.:

Primary Outcome Measures:
  • Rate and Extend of Absorption [ Time Frame: 120 hours ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: August 2004
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Abrika Bupropion 150 mg Extended-Released Tablet, single dose
Drug: Abrika Bupropion 150 mg Extended-Released Tablet
A: Experimental Subjects received Abrika formulated products under fasting conditions
Other Name: Bupropion
Active Comparator: B
Wellbutrin SR® 150 mg Extended-Release Tablet, single dose
Drug: Wellbutrin SR® 150 mg Extended-Release Tablet, single dose
B: Active comparator Subjects received GlaxoSmithKline formulated products under fasting 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 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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00865410

Locations
United States, Florida
SFBC Ft. Myers, Inc.
Ft. Myers, Florida, United States, 33901
Sponsors and Collaborators
Actavis Inc.
Investigators
Principal Investigator: Antonio R. Pizarro,, M.D. SFBC Ft. Myers, Inc
  More Information

Additional Information:
No publications provided

Responsible Party: Meena Venugopal, Director, Clinical R&D, Actavis Inc
ClinicalTrials.gov Identifier: NCT00865410     History of Changes
Other Study ID Numbers: 04-0646-009
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 August 21, 2014