Bioequivalence of Generic Bupropion (U01)
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.
General information about this opportunity
Last Known Status
Deleted 06/30/2013 (Archived.)
Program Number
RFA-FD-13-021 Federal Agency/Office
Agency: Department of Health and Human ServicesOffice: Food and Drug Administration
Type(s) of Assistance Offered
Cooperative Agreement Number of Awards Available
1 Who is eligible to apply/benefit from this assistance?
Applicant Eligibility
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. What is the process for applying and being award this assistance?
Deadlines
05/31/2013 Other Assistance Considerations
Formula and Matching Requirements
This program does not have cost sharing or matching requirements. Who do I contact about this opportunity?
Headquarters Office
Lisa KoGrants Management Specialist
Website Address
http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-13-021.html
E-mail Address
lisa.ko@fda.hhs.gov
Financial Information
Obligations
$800,000.00 Range and Average of Financial Assistance
Awards up to $800,000.00
