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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.
- 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.)
- Subjects :
- Adult
Antidepressive Agents, Second-Generation adverse effects
Antidepressive Agents, Second-Generation pharmacokinetics
Bupropion adverse effects
Bupropion pharmacokinetics
Cross-Over Studies
Double-Blind Method
Drugs, Generic adverse effects
Female
Humans
Male
Middle Aged
Prospective Studies
Therapeutic Equivalency
Treatment Outcome
Antidepressive Agents, Second-Generation therapeutic use
Bupropion therapeutic use
Depressive Disorder, Major drug therapy
Drugs, Generic therapeutic use
Subjects
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