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

NCT ID: NCT00883155

Last Updated: 2017-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-10-31

Study Completion Date

1998-10-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Bupropion HCl 100 mg Tablets (Invamed Inc.)

Group Type EXPERIMENTAL

Bupropion HCl 100 mg Tablets (Invamed Inc.)

Intervention Type DRUG

2

Wellbutrin 100 mg Tablets (Glaxo Wellcome)

Group Type ACTIVE_COMPARATOR

Wellbutrin 100 mg Tablets (Glaxo Wellcome)

Intervention Type DRUG

Interventions

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Bupropion HCl 100 mg Tablets (Invamed Inc.)

Intervention Type DRUG

Wellbutrin 100 mg Tablets (Glaxo Wellcome)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sandoz

INDUSTRY

Sponsor Role lead

Responsible Party

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Sandoz Inc.

Principal Investigators

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Jameel Razack, M.D.

Role: PRINCIPAL_INVESTIGATOR

Pharma Medica Research, Inc.

Other Identifiers

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B-09018

Identifier Type: -

Identifier Source: org_study_id

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