Bioequivalence Study of Paroxetine Hydrochloride Film-Coated Tablets
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Department of Pharmacy， The Second Affiliated Hospital of Soochow University， Suzhou 215004， China
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History+
Received
Revised
Published
2011-04-20
2011-04-20
2012-03-10
Issue Date
2012-04-14
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； AUC0~96 h (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.
Bioequivalence Study of Paroxetine Hydrochloride Film-Coated Tablets[J]. Chinese Pharmaceutical Journal, 2012, 47(5): 367-370
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References
[1] LIU W Z， HUANG W Q， WANG G F， et al. Pharmacokinetic characteristics and bioequivalence of Paroxetine tablets in healthy Chinese volunteers [J]. Her Med. (医药导报)， 2007， 26 (6)： 588-591. [2] LIN Z G，LI H F，WENG Y R， et al. Bioequivalence of paroxetine tablets in healthy volunteers [J]. Chin J Clin Pharm (中国临床药学杂志)， 2005， 14 (4)： 231-233. [3] KO I J， CHI S C. Bioequivalence of Paroxetine Tablet to Seroxat Tablet (Paroxetine 20 mg) [J]. J Kor Pharm Sci， 2004， 34 (6)： 499-504.
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