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

NCT00865111 · 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 Abrika Bupropion 150 mg sustained release tablet to that of Wellbutrin SR sustained release tablet after a single, one-tablet dose in fasted subjects.

Conditions

  • Healthy

Interventions

DRUG

Bupropion 150 mg Extended-Released Tablet, single dose

A: Experimental Subjects received Abrika formulated products under fasting conditions

DRUG

Wellbutrin SR® 150 mg Sustained-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
2006-03-31
Primary Completion
2006-04-30
Completion
2006-04-30

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 NCT00865111 on ClinicalTrials.gov