Table of Contents

Page #

Synopsis

1

Recommendation

2

Background

4

Summary of Bioavailability/Bioequivalence Studies

6

Comments

APPENDIX I (Summary of Study Reports):

Pilot or Background Studies

Study 96:               Steady-State Pharmacokinetics of Two Daily Oral  Doses of WELLBUTRIN® and Its Basic Metabolites in Normal Volunteers.

14

Study 201:             Single-Dose Bioequivalence of WELLBUTRIN® Immediate Release Tablets in Healthy Male Volunteers.

20

Study 204:             A Single-Dose Bioavailability Evaluation of the 50 and 100 mg WELLBUTRIN® Sustained Release Tablets in Healthy Male Volunteers.

28

Pivotal Bioavailability/Bioequivalence Studies:

Study 202:             A Single-Dose Bioequivalence/Effect of Food Evaluation of WELLBUTRIN® Sustained Release.

33

Study 206:             Steady-State Bioequivalence Evaluation of Bupropion Sustained Release and Bupropion Immediate Release Tablets in Healthy Male Volunteers.

40

Study 207:             A Bioequivalency Study of 50, 100, and 150 mg Bupropion Sustained Release Tablets in Healthy Male Volunteers.

48

Dissolution

56