NCT00864981

Brief Summary

The purpose of this study is to demonstrate the relative bioequivalence of Bupropion HCI 150 mg SR Tablets under fasting conditions.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_1 depression

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_1 depression

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2009

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2009

Enrollment Period

1 month

First QC Date

March 13, 2009

Last Update Submit

March 27, 2017

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence according to US FDA timelines

    29 days

Study Arms (2)

1

EXPERIMENTAL

Bupropion HCI ER Tablets, 150 mg

Drug: Bupropion HCI ER Tablets, 150 mg; EON Labs Inc.

2

ACTIVE COMPARATOR

WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg

Drug: WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg; GlaxoSmithKline

Interventions

Bupropion HCI ER Tablets, 150 mg; EON Labs Inc.DRUG
1
WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg; GlaxoSmithKlineDRUG
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

You may not qualify if:

  • Positive test results for HIV or hepatitis B or C.
  • Treatment for drug or alcohol dependence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depression

Interventions

Bupropionhalofantrine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Study Officials

  • Shirley A Kennedy, M.D.

    Novum Pharmaceutical Research Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 13, 2009

First Posted

March 19, 2009

Study Start

September 1, 2005

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

March 29, 2017

Record last verified: 2009-03