OBJECTIVE: The
pharmacokinetics and relative
bioavailability of domestic film coating special shaped tablet of acetaminophen were studied in 10 healthy male volunteers METHOD: A single oral dose of 500 mg of the two formations (test and reference preparation) was given in a randomized 2 way cross over design Blood samples were withdrawn up to 10 hours post administration Plasma concentrations of acetaminophen were assayed by HPLC RESULTS: The concentration time profiles of two
preparations fitted to a one compartment model with first order absorption and lag time The main
Pharmacokinetic parameters of the test
preparation were as following c max (5 51±1 24)mg·L -1 , t max (1 03±0 43)h, t 1/2ka (0 27±0 16)h, t 1/2ke (2 60±0 51)h,
AUC 0～∞ (34 91±7 96)mg·h·L -1 ,MRT(3 65±0 22)h,respetively The main pharmacokinetic parameters of the reference preparation were as following: c max (5 81±1 01)mg·L -1 , t max (0 88±0 32)h, t 1/2ka (0 14±0 07)h, t 1/2ke (2 71±0 93)h, AUC 0～∞ (33 14±5 67)mg·h·L -1 ,MRT (3 60±0 10)h, respectively CONCLUSION: The relative bioavailability of the test preparation was (108 29±22 15)% to the reference preparation, indicating that the two kinds of preparations are bioequivalent preparations
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