A Relative Bioavailability Study of Bupropion HCI 150 mg Sustained-Release Tablets Under Fasting Conditions

This study has been completed.

Sponsor:

Information provided by:

Sandoz

ClinicalTrials.gov Identifier:

NCT00864981

First received: March 13, 2009

Last updated: March 18, 2009

Last verified: March 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

March 13, 2009

Last Updated Date

March 18, 2009

Start Date ^ICMJE

September 2005

Primary Completion Date

October 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Bioequivalence according to US FDA timelines [ Time Frame: 29 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00864981 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Relative Bioavailability Study of Bupropion HCI 150 mg Sustained-Release Tablets Under Fasting Conditions

Official Title ^ICMJE

A Relative Bioavailability Study of Bupropion HCI 150 mg Sustained-Release Tablets Under Fasting Conditions

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Depression

Intervention ^ICMJE

Drug: Bupropion HCI ER Tablets, 150 mg; EON Labs Inc.
Drug: WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg; GlaxoSmithKline

Study Arm (s)

Experimental: 1
Bupropion HCI ER Tablets, 150 mg

Intervention: Drug: Bupropion HCI ER Tablets, 150 mg; EON Labs Inc.
Active Comparator: 2
WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2005

Primary Completion Date

October 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00864981

Other Study ID Numbers ^ICMJE

B052005

Has Data Monitoring Committee

Not Provided

Responsible Party

Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.

Study Sponsor ^ICMJE

Sandoz Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Shirley A Kennedy, M.D.

Novum Pharmaceutical Research Services

Information Provided By

Sandoz

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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