Bioequivalence study of paroxetine hydrochloride film-coated tablets / 中国药学杂志
Chinese Pharmaceutical Journal
;
(24): 367-370, 2012.
Artigo
em Chinês
| WPRIM
| ID: wpr-860806
ABSTRACT
OBJECTIVE:
To evaluate the relative bioavailibility and bioequivalence of paroxetine hydrochloride film-coated tablets.METHODS:
In a randomized crossover study, 24 healthy Chinese male subjects received a single oral dose (20 mg) of either test or reference paroxetine hydrochloride tablets after an overnight fast. The plasma concentrations of paroxetine were determined by a validated LC-MS/MS method. The pharmacokinetic parameters, the relative bioavailability and bioequivalence of two formulations were evaluated by DAS 2.0 software.RESULTS:
After a single oral dose of 20 mg test or reference paroxetine tablets, the pharmacokinetic parameters of paroxetine were as follows ρmax(5.102 ± 2.955) and (5.396 ± 2.852) μg · L-1; tmax (5.22 ± 1.83) and (5.35 ± 0.78) h; t1/2(11.76 ± 2.91) and (11.98 ± 3.57) h; AUC0~96h(118.1 ± 90.2) and (118.9 ± 86.0) μg · h · L-1; AUC0-∞ (120.2 ± 91.0) and (121.5 ± 87.6) μg · h · L-1, respectively.CONCLUSION:
The relative bioavailability of the test paroxetine hydrochloride film-coated tablets is (100.6 ± 22.0)%. The two preparations are bioequivalent. Copyright 2012 by the Chinese Pharmaceutical Association.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Tipo de estudo:
Ensaio Clínico Controlado
Idioma:
Chinês
Revista:
Chinese Pharmaceutical Journal
Ano de publicação:
2012
Tipo de documento:
Artigo
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