OpportunityTitle: Bioequivalence of Generic Bupropion (U01)
AdditionalInformationOnEligibility: Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.    Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.    Foreign components, as defined in the HHS Grants Policy Statement, are allowed.
Description: The purpose of the study is to (1) demonstrate bioequivalence between generic and brand name bupropion HCl modified release products with different release patterns at steady state in patients, and (2) evaluate whether patients can perceive the difference in release pattern and experience lack of efficacy or increased adverse events after they are switched between each treatment. The outcome of this study will help address concerns on quality, bioequivalence, and therapeutic equivalence of bupropion hydrochloride modified release generic products.
GrantorContactEmailDescription: lisa.ko@fda.hhs.gov
GrantorContactText: Lisa Ko &lt;br/&gt;Grants Management Specialist