NCT00883155

Brief Summary

To Demonstrate the Relative Bioavailability of Bupropion HCI 100 mg Tablets under Fasting Conditions.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Oct 1998

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

October 1, 1998

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 1998

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 1998

Completed
10.5 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 17, 2009

Completed
Last Updated

March 29, 2017

Status Verified

April 1, 2009

Enrollment Period

Same day

First QC Date

April 16, 2009

Last Update Submit

March 27, 2017

Conditions

Healthy

Keywords

Antidepressant

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on AUC and Cmax

    29 days

Study Arms (2)

1

EXPERIMENTAL

Bupropion HCl 100 mg Tablets (Invamed Inc.)

Drug: Bupropion HCl 100 mg Tablets (Invamed Inc.)

2

ACTIVE COMPARATOR

Wellbutrin 100 mg Tablets (Glaxo Wellcome)

Drug: Wellbutrin 100 mg Tablets (Glaxo Wellcome)

Interventions

Bupropion HCl 100 mg Tablets (Invamed Inc.)DRUG
1
Wellbutrin 100 mg Tablets (Glaxo Wellcome)DRUG
2

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
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 or C.
  • Treatment for drug or alcohol dependence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Bupropion

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Study Officials

  • Jameel Razack, M.D.

    Pharma Medica Research, Inc.

    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

April 16, 2009

First Posted

April 17, 2009

Study Start

October 1, 1998

Primary Completion

October 1, 1998

Study Completion

October 1, 1998

Last Updated

March 29, 2017

Record last verified: 2009-04