The relative
bioavailability of domestic acemetacin sustained_release
capsules was studied after single and multiple
oral dose given to 12 healthy male volunteers in
a randomized crossover study.Active metabolite
indometacin of acemetacin in serum was
detected by reversed-phase HPLC. After a single oral dose(90 mg) Cmax of indometacin were 0.
9830.298 mgL-1 and 1.0120.286 mgL-1,Tpeak 3.0000.603 h and 3.0831.084 h,AUC0- 6.4732.437
mghL-1 and 6.5251.992 mghL-1 for domestic acemetacin sustained_release capsules and
imported acemetacin sustained_release capsules (Rantudil Retard). The relative
bioavailability of domestic sustained_released capsules was 99.7823.79%.Following multiple
dose schedule(90 mg,qd7 d), Css,max of indometacin were 1.080.25 mgL-1and 1.060.36 mgL-1,
Css,min 0.060.02 mgL-1 and 0.070.02 mgL-1,and AUC0-t6.221.81 mghL-1 and 6.111.84 mghL-1
for domestic acemetacin sustained_release capsules and Rantudil Retard.The fluctuation index
for two preparations were 1.780.07 and 1.760.0 6 respectively.The relative bioavailability of
domestic sustained_released capsules was 104.1018.80%.To AUC0-(single dose) and
AUC0-t(multiple dose),the result of two one_sided tests showed that the two preparations were
bioequivalent.