CClinicalTrials.gg
CompletedNCT00865111Updated Aug 16, 2010

A Relative Bioavailability Study of Bupropion Sustained Release 150 mg Tablets Under Fasting Conditions

A Phase 1 interventional study of Bupropion 150 mg Extended-Released Tablet, single dose and Wellbutrin SR® 150 mg Sustained-Release Tablet, single dose in Healthy, sponsored by Actavis Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-08-16.

Sponsored by Actavis Inc. · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

The purpose of this study is to compare the rate and extent of absorption of Abrika Bupropion 150 mg sustained release tablet to that of Wellbutrin SR sustained release tablet after a single, one-tablet dose in fasted subjects.

Read the 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 Sustained Release Tablets in Fasted, Normal, Healthy Men.

Further study details as provided by Actavis Elizabeth LLC:

Primary Outcome Measures:

Rate and Extend of Absorption

02

Conditions studied

  • Healthy

Keywords

  • Bioequivalence
  • Bupropion
  • Healthy subjects
03

In context

Lead sponsor

Actavis Inc. is the lead sponsor of 94 studies on the registry; none are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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 between 19 and 30, inclusive?
  • 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

Exclusion Criteria:

  • Does the individual have a history of allergy or hypersensitivity to bupropion?
  • 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/her safety?
  • Does he have serious psychological illness?
  • Does he have significant history (within the past year) 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?
  • Has he consumed grapefruit or grapefruit juice during the 7-day period preceding study initiation?
  • Is he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period?
  • Has he used any prescription drug during the 14-day period prior to study initiation, 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?
  • Is he a heavy smoker (usually smoking more than 25 cigarettes per day? A yes answer to any of the above questions indicates that the individual is ineligible for enrollment
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    A

    Bupropion 150 mg Extended-Released Tablet, single dose

    Drug: Bupropion 150 mg Extended-Released Tablet, single dose

  • Active comparator
    B

    Wellbutrin SR® 150 mg Sustained-Release Tablet, single dose

    Drug: Wellbutrin SR® 150 mg Sustained-Release Tablet, single dose

Interventions

  • DrugBupropion 150 mg Extended-Released Tablet, single dose

    A: Experimental Subjects received Abrika formulated products under fasting conditions

    Also known as: Bupropion

  • DrugWellbutrin SR® 150 mg Sustained-Release Tablet, single dose

    B: Active comparator Subjects received GlaxoSmithKline formulated products under fasting conditions

    Also known as: Bupropion

06

What researchers measure

Primary outcomes

  1. Rate and Extend of Absorption

    Time frame: 120 hours

07

Study locations

1 site
  • SFBC Ft. Myers, Inc.
    Ft. Myers, Florida 33901, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00865111
Lead sponsor
Actavis Inc.
First posted
Mar 19, 2009
Start date
Mar 2006
Primary completion
Apr 2006
Completion
Apr 2006
Last update
Aug 16, 2010

Study contacts

Antonio R. Pizarro,, M.D.
principal investigator · SFBC Ft. Myers, Inc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.

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