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A Relative Bioavailability Study of Bupropion Extended-Released 150 mg Tablets Under Fasting Conditions

NCT00865410 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2010-08-16

No results posted yet for this study

Summary

The purpose of this study is to compare the rate and extent of absorption of Bupropion HCl extended-release tablet (test) to that of Wellbutrin SR extended-release tablet (reference) after a single, one-tablet (150 mg) dose in fasted subjects.

Conditions

  • Healthy

Interventions

DRUG

Abrika Bupropion 150 mg Extended-Released Tablet

A: Experimental Subjects received Abrika formulated products under fasting conditions

DRUG

Wellbutrin SR® 150 mg Extended-Release Tablet, single dose

B: Active comparator Subjects received GlaxoSmithKline formulated products under fasting conditions

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • Antonio R. Pizarro,, M.D. · SFBC Ft. Myers, Inc

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-08-31
Primary Completion
2004-09-30
Completion
2004-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00865410 on ClinicalTrials.gov