NCT00861939

Brief Summary

The purpose of this study is to demonstrate the relative bioequivalence of Bupropion HCI 300 mg ER Tablets under fasting conditions.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 depression

Timeline
Completed

Started Mar 2004

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

March 1, 2004

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 16, 2009

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2009

Enrollment Period

1 month

First QC Date

March 12, 2009

Last Update Submit

March 27, 2017

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence according to US FDA timelines

    17 days

Study Arms (2)

1

EXPERIMENTAL

Bupropion HCl 300mg Extended Release Tablet

Drug: Bupropion HCI 300 mg Extended-Release Tablets EON

2

ACTIVE COMPARATOR

WELLBUTRIN XL 300mg Tablets

Drug: WELLBUTRIN XL 300 mg Extended-Release Tablets GlaxoSmithKline

Interventions

Bupropion HCI 300 mg Extended-Release Tablets EONDRUG
1
WELLBUTRIN XL 300 mg Extended-Release Tablets GlaxoSmithKlineDRUG
2

Eligibility Criteria

Age18 Years - 58 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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 orc.
  • 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

  • So R Hong, 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 12, 2009

First Posted

March 16, 2009

Study Start

March 1, 2004

Primary Completion

April 1, 2004

Study Completion

April 1, 2004

Last Updated

March 29, 2017

Record last verified: 2009-03