[Study on relative bioavailability of aspirin in afenca tablet].
Salicylic acid is a kind of active metabolite of aspirin in vivo. In this study, its concentration in plasma was detected by RP-HPLC after twenty four healthy male volunteers were given each a single dose of oral Afenca test and reference preparations. The experiment data were calculated with 3P97 program. The results were analyzed by ANOVA and two- and one-sided t tests. The relative bioavailability of salicylic acid was 105.36% +/- 14.15%; AUC0-T of salicylic acid of test and reference preparations were 103.10 +/- 11.92 micrograms.h/ml and 98.45 +/- 13.49 micrograms.h/ml respectively; Tmax were 1.5 +/- 0.5 h and 1.5 +/- 0.5 h; Cmax were 19.31 +/- 2.47 micrograms/ml and 18.95 +/- 2.49 micrograms/ml. Bioequivalent evaluation of two preparations by analyzing with two- and one-sided t tests showed that the two preparations were bioequivalent on the basis of salicylic acid (t1 > or = t1-0.05(22), t2 > or = t1-0.06(22)).
Yang
Junyi
J
School of Pharmacy, Sichuan University, Chengdu 610041.
Jiang
Xuehua
X
He
Lin
L
Zhou
Jing
J
Li
Suhua
S
Lin
Shu
S
D000284:Administration, Oral; D000328:Adult; D019540:Area Under Curve; D001241:Aspirin / Q000008:administration & dosage / Q000493:pharmacokinetics*; D018592:Cross-Over Studies; D006801:Humans; D008297:Male; D020156:Salicylic Acid / Q000097:blood; D013607:Tablets; D013810:Therapeutic Equivalency
D013607:Tablets; D020156:Salicylic Acid; D001241:Aspirin