Bioequivalence of Generic Bupropion (U01)

Post Date

April 2nd 2013

Application Due Date

May 31st 2013

Funding Opportunity Number

RFA-FD-13-021

CFDA Number(s)

93.103

Funding Instrument Type(s)

Cooperative Agreement

Funding Activity Categories

Consumer Protection
Food and Nutrition
Health

Number of Awards

1

Eligibility Categories

State Governments
County Governments
City or Township Governments
Special District Governments
Independent School Districts
Public and State Controlled Institutions of Higher Education
Federally Recognized Native American Tribal Governments
Public Housing Authorities or Indian Housing Authorities
Non-Federally Recognized Native American Tribal Organizations
Non-Profits With 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Non-Profits Without 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Private Institutions of Higher Education
For-Profit Organizations (Except Small Businesses)
Small Businesses
Other

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.

Funding

• Estimated Total Funding:

  $800000

• Award Range:

  $None - $800000

Grant 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.

Contact Information

• Agency

  Department of Health and Human Services

• Office:

  Food and Drug Administration

• Agency Contact:

  Lisa Ko
  Grants Management Specialist

• Agency Mailing Address:

  lisa.ko@fda.hhs.gov

• Agency Email Address:

  lisa.ko@fda.hhs.gov

• More Information:

  Link to Full Announcement of RFA-FD-13-021 on NIH Guide for Grants and Contracts