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Shvoong Home>Medicine & Health>Evaluation of bioavailability and pharmacokinetics of film-coating special shaped tablet of acetamin Summary

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Evaluation of bioavailability and pharmacokinetics of film-coating special shaped tablet of acetamin

Article Abstract by: TsingHua     

Original Author: Chinese Journal of Clinical Pharmacology and Therapeutics
Aim The pharmacokinetics and relative bioavailability of domestic film_coating special shaped tablet of acetaminophen were
studied.Methods A single oral dose of 500 mg of the two formations (test and reference preparation) was given to 10 healthy male volunteers according to randomized 2_way cross_over design, blood sample was withdrawn 10 hours after administration, and plasma concentrations of acetaminophen were assayed by a high performance liquid chromtography (HPLC) method. Results The concentration_time curves of the two preparations fitted to a one_compartment model with first order absorption and lag time. The main pharmacokinetic parameters of the tested preparation were as follows:Cmax=5.51±1.24 mg/L, Tpeak=1.03±0.43 h, T 1/2ka=0.27±0.16 h, T1/2ke=2.60±0.51 h,AUC0?t=23.69±4.08 mg·h·L-1,MRT=3.65±0.22 h. Conclusion The relative bioavailability of the test preparation is 102.5±13.3% to the reference preparation . The bioavailabity of the two kinds of acetaminophen is equal , showing that the two kinds of preparations are bioequivalent preparations.
Published: December 26, 1998
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