OBJECTIVE To study the
pharmacokinetics and
bioequivalence of sustained release
allopurinol tablets in healthy volunteers METHODS A single and multiple oral administration of test and reference tablets were given to healthy male volunteers according to the randomized crossover design Plasma concentrations of allopurinol and
oxypurinol were determined by HPLC UV The
Pharmacokinetic parameters of test tablets were compared with those of the reference tablets RESULTS After a single oral administration of test and reference tablets,the pharmacokinetic parameters of allopurinol were as follows:AUC 0～12 were(4 58±1 52)mg·h·L -1 and(4 43±1 40)mg·h·L -1 , t max were(2 00±0 41)h and(1 25±0 41)h,and c max were(1 75±0 49)mg·L -1 and(2 06±0 40)mg·L -1 ,respectively The pharmacokinetic parameters of oxypurinol were as follows:AUC 0～72 were(123 94±23 39)mg·h·L -1 and(126 52±27 47)mg·h·L -1 , t max were(6 42±3 47)h and(4 18±1 59)h,and c max were(3 70±0 52)mg·L -1 and(3 99±0 61)mg·L -1 ,respectively After multiple oral administration of test and reference tablets,the pharmacokinetic parameters of oxypurinol were as follows: c min were(4 41±0 76)mg·L -1 and(4 07±0 76)mg·L -1 , c max were(7 33±1 31)mg·L -1 and(7 31±1 25)mg·L -1 , t max were(2 58± 1 44)h and(5 68±2 03)h,and DF were(0 52±0 18)and(0 58±0 13),respectively CONCLUSIONS As to absorption extent,the test tablets orally administered 250 mg once daily is bioequivalent to the reference tablets given twice daily at the same dose
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