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Bioequivalence and Therapeutic Equivalence of Generic and Brand Bupropion in Adults With Major Depression: A Randomized Clinical Trial.

Bioequivalence and Therapeutic Equivalence of Generic and Brand Bupropion in Adults With Major Depression: A Randomized Clinical Trial.

Authors :
Kharasch ED
Neiner A
Kraus K
Blood J
Stevens A
Schweiger J
Miller JP
Lenze EJ
Source :
Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2019 May; Vol. 105 (5), pp. 1164-1174. Date of Electronic Publication: 2019 Jan 18.
Publication Year :
2019

Abstract

Controversy persists about bupropion XL 300 mg generic equivalence to brand product. A prospective, randomized, double-blinded crossover in 70 adults with major depression in stable remission taking any bupropion XL 300 mg tested bioequivalence and therapeutic equivalence of available XL 300 mg products. After a 4-week lead-in on patients' existing bupropion, four 6-week phases evaluated brand and three generics. Patients were uninformed of switching. Drug overencapsulation ensured blinding. There were no differences between any generic and brand, or between generics, in peak plasma concentration (C <subscript>max</subscript> ) and area under the plasma concentration-time curve over the 24-hour dosing interval (AUC <subscript>0-24</subscript> ) for racemic bupropion or major metabolites. All generics met formal bioequivalence criteria for bupropion and metabolites. There were no differences between generics and brand, or between generics, in depression symptoms or side effects, assessed by every 3-week in-person interview and daily smartphone-based self-report. There were no differences in patients' perceptions of bupropion products. Results show three bupropion XL 300 mg generic products are both bioequivalent and not therapeutically different from brand drug and each other.<br /> (© 2018 The Authors Clinical Pharmacology & Therapeutics © 2018 American Society for Clinical Pharmacology and Therapeutics.)

Details

Language :
English
ISSN :
1532-6535
Volume :
105
Issue :
5
Database :
MEDLINE
Journal :
Clinical pharmacology and therapeutics
Publication Type :
Academic Journal
Accession number :
30460996
Full Text :
https://doi.org/10.1002/cpt.1309