Pharmacokinetic Study of Bupropion Hydrochloride Products with Different Release Patt. Page 1 of 3
Pharmacokinetic Study of Bupropion Hydrochloride Products with Different Release Patterns Solicitation Number: 1116087 Agency: Department of Health and Human Services Office: Food and Drug Administration Location: Office of Acquisitions and Grants Services Notice Type: Posted Date: Response Date: Archiving Policy: Original Set Aside: Archive Date: May 7, 2013 Set Aside: N/A Classification Code: A -- Research & Development NAICS Code: 541 -- Professional, Scientific, and Technical Services/541712 -- Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology) Synopsis: Added: Apr 12, 2013 11:44 am This is a Sources Sought Notice to determine the availability and capability of Small Businesses capable of performing the services as described in the body of this notices. This notice is for planning purposes only, and does not constitute an Invitation for Bids, Request for Proposals or Request for Quotation or an indication the Government will contract for the services described herein. This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. The applicable North American Industry Classification System (NAICS) code is 541712, Research and Development in the Physical, Engineering and Life Sciences with a size standard of 500 employees. The U.S. Food and Drug Administration's Center for Drug Evaluation and Research Office of Generic Drugs (FDA/CDER/OGD) is seeking to identify sources that can conduct a two year Pharmacokinetic Study of Bupropion Hydrochloride products with different release patterns with the minimum requirements listed below. Background.
Bupropion is indicated for the treatment of major depressive disorder (MDD), for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder, or as an aid to smoking cessation treatment depending on the dosage forms. Bupropion hydrochloride (HCl) has been formulated as immediate-release (IR) formulation (dosed three times a day), sustained-release (SR) formulation (dosed twice a day), and extended-release (ER) formulation (dosed once a day).
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Recently, the FDA announced withdrawal of a generic bupropion HCl extended release product for nonbioequivalence (Budeprion XL 300 mg) based on the results from a bioequivalence study comparing Budeprion XL (300 mg) tablets with Wellbutrin XL (300 mg) tablets. The approval of the 300 mg bupropion HCl extended release tablets was based on acceptable bioequivalence studies on 150 mg bupropion HCl extended release tablets, acceptable dissolution studies in multiple media, and formulation proportional similarity. Understanding the scientific basis causing the failure of the 300 mg tablets is important for future guidance development and review processes. It is noted that the generic version had different formulation design as the reference product so that the generic product releases earlier in the gastrointestinal (GI) tract. One of the hypotheses for the failure of bioequivalence study on the 300 mg tablets is that bupropion is eliminated differently in the GI tract due to the different in vivo release patterns. In addition, subjects with different metabolic genotypes may have different sensitivity in terms of differencing the differences. Pharmacokinetic study of bupropion HCl products with different release patterns at different dose levels will help understand the underlining mechanisms.
For the purpose of the project, single dose in vivo crossover pharmacokinetic studies of bupropion HCl products with different release patterns (IR, SR, and ER) at multiple dose levels in healthy subjects (general population ) shall be required . The inclusion and exclusion criteria shall be specified in the protocol and submitted to the FDA's Institutional Review Board (IRB), the Research Involving Human Subjects Committee (RIHSC) for review and approval. The maximum doses should not exceed 100 mg, 200 mg, and 300 mg for IR, SR, and ER products, respectively. Each subject will be administered one dose of the following bupropion HCl products: 75 mg (IR), 100 mg (IR), 100 mg (SR), 200 mg (SR), 2×100 mg (SR), 150 mg (XL), 300 mg (XL), and 2×150 mg (XL). A total number of 36 subjects are expected to be recruited including dropouts. Generic versions should be used for the study. Different dose strengths of IR, SR, and ER bupropion HCl products shall be from the same product line. (For example the two ER bupropion HCl strengths should be from the same manufacturer) . Plasma concentration of bupropion and its three active metabolites (hydroxybupropion, threohydrobupropion, and erythrohydrobupropion) shall be measured for each sampling point. The genotypes of cytochrome P450 (CYP)2B6 in each subject shall also be identified. If other enzymes have been found to significantly affect the bupropion or its metabolites pharmacokinetics based on previous knowledge, literatures and publications, the genotype of those enzymes in each subject shall also be identified.
Deliverables for this contract shall include all raw data collected from the experiments, progress and final reports to include description of experiments and data analysis, and presentations at the FDA . The presentation shall be a summary of the significant findings from the study.
Parties submitting capability statements shall be advised that generic capability statements are not sufficient for effective for evaluation of respondents' capacity and capability of providing the required services. Respondents should limit their capability statements to no more than ten (10) pages in length, excluding standard brochures, technical literature and any other information that demonstrates the capabilities of the contractor to meet the Government's requirement. Provide two contact names, email and phone numbers for similar projects that may be contacted by the Government. Potential contractors must indicate business size, proof of any set-aside certification and company's DUNS number and provide a contact name, the mailing address, phone number, email address of point of contact and reference #1116087. Identification of any
Pharmacokinetic Study of Bupropion Hydrochloride Products with Different Release Patt. Page 3 of 3
applicable GSA contract number, schedule number, SIN number that may be applicable to this potential requirement are also requested.
Interested parties must respond with capability statements in person on or before April 22, 2013 by 1:00 PM (Central Time) Jefferson, Arkansas, at the Food and Drug Administration, Office of Acquisitions and Grants Services, Field Operations Branch, Attn: Marcia Park, 3900 NCTR Road, HFT-322, Jefferson, AR 72079-9502; Faxed to 870/543-7990 or emailed to [email protected]. Contracting Office Address: 3900 NCTR Road, HFT-320 Bldg 50 | Rm 421 Jefferson, Arkansas 72079 United States Place of Performance: Contractor Facility United States Primary Point of Contact.: Marcia O Park, Contract Specialist [email protected] Phone: (870) 543-7405 Fax: (870) 543-7990 Opportunity History
■ Original Synopsis
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