1.  Executive Summary .................................................................................................................................

1

    1.1  Recommendations and Comments to Sponsor ......................................................................................

3

Table of Contents .........................................................................................................................................

4

Summary of Clinical Pharmacology and Biopharmaceutics Findings .................................................................

5

    4.1  Background .......................................................................................................................................

5

    4.2 Current Submission .............................................................................................................................

5

    3.2.1  Dissolution Specifications ................................................................................................................

5

    3.2.2  Evaluation of the Potential for Drug Interactions ...............................................................................

6

    4.3  Recommendations .............................................................................................................................

11