NCT00883155

CompletedPhase 1

To Demonstrate the Relative Bioavailability of Bupropion HCI...

Sandoz Source

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Other study identifiers

Sponsor study identifier

B-09018

Study Type

interventional

Actual enrollment (reported)

36

Locations

0 countries

Sites

N/A

Timeline

Study Start

October 1998

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

October 1998

Actual (reported)

Study Completion

October 1998

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 36 participants
Study completion date: October 1998
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
October 1998
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
October 1998
Actual (reported)
Study Completion
October 1998
Actual (reported)
First Submitted
April 16, 2009
Actual (reported)
First Posted
April 17, 2009
Actual (reported)

Last Updated: March 29, 2017
Status Verified: April 2009
Last Update Submitted: 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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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:

Sponsors & Collaborators

Sandoz
Industrylead

MeSH Terms

Interventions

Bupropion

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Study Officials

Jameel Razack, M.D.
Pharma Medica Research, Inc.
PRINCIPAL INVESTIGATOR

Enrollment

36 participants (actual enrollment reported by the registry).

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 1998

Date type not reported

This date has not been verified as actual or estimated.

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Positive test results for HIV or hepatitis B or C.

Treatment for drug or alcohol dependence.

Contact the study team to confirm eligibility.

Primary Completion

October 1998

Actual (reported)

Study Completion

October 1998

Actual (reported)

Last Updated

March 29, 2017

Record last verified: 2009-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00883155
Data provider: ClinicalTrials.gov
Source updated: 2017-03-29
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:35:34 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record