Title: Pharmacokinetics and bioequivalence of trimetazidine dihydrochloride tablet in healthy volunteers
Abstract: OBJECTIVE To study the relative bioavailability of domestic and imported trimetazidine dihydrochloride tablets in healthy human subjects and its bioequivalence.METHODS In a randomized crossover study,20 healthy male volunteers was given a single oral dose of 20 mg trimetazidine dihydrochloride tablets.The concentration of trimetazidine in plasma was determined by HPLC-MS.The pharmacokinetic parameters were processed by DAS program for statistic analysis.RESULTS The pharmacokinetic parameters of the test and reference tablets were as follows: Cmax were(65.0±13.6) and(65.1±11.8)μg·L-1;tmax were(2.2±0.8) and (1.9±0.5) h;AUC0-24h were(591.5±119.6) and(576.6±112.8)μg·L-1·h;t1/2 were(5.5±0.6) and (5.4±0.5)h,respectively.The relative bioavailability of the test tablets was(102.8±8.8)%.There was no significant difference in tmax,Cmax,AUC0-24h and between the two preparations.The 90% confidential interval of Cmax and AUC0-24h were between 95.0%-103.5% and 99.1%-106.0% of those of reference tablets.CONCLUSION The domestic and imported trimetazidine dihydrochloride tablet were bioequivalent.
Publication Year: 2007
Publication Date: 2007-01-01
Language: en
Type: article
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