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
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