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[Study on relative bioavailability of aspirin in afenca tablet]. 2003

Junyi Yang, and Xuehua Jiang, and Lin He, and Jing Zhou, and Suhua Li, and Shu Lin
School of Pharmacy, Sichuan University, Chengdu 610041.

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)).

UI MeSH Term Description Entries
D008297 Male Males
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000284 Administration, Oral The giving of drugs, chemicals, or other substances by mouth. Drug Administration, Oral,Administration, Oral Drug,Oral Administration,Oral Drug Administration,Administrations, Oral,Administrations, Oral Drug,Drug Administrations, Oral,Oral Administrations,Oral Drug Administrations
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D001241 Aspirin The prototypical analgesic used in the treatment of mild to moderate pain. It has anti-inflammatory and antipyretic properties and acts as an inhibitor of cyclooxygenase which results in the inhibition of the biosynthesis of prostaglandins. Aspirin also inhibits platelet aggregation and is used in the prevention of arterial and venous thrombosis. (From Martindale, The Extra Pharmacopoeia, 30th ed, p5) Acetylsalicylic Acid,2-(Acetyloxy)benzoic Acid,Acetysal,Acylpyrin,Aloxiprimum,Colfarit,Dispril,Easprin,Ecotrin,Endosprin,Magnecyl,Micristin,Polopirin,Polopiryna,Solprin,Solupsan,Zorprin,Acid, Acetylsalicylic
D013607 Tablets Solid dosage forms, of varying weight, size, and shape, which may be molded or compressed, and which contain a medicinal substance in pure or diluted form. (Dorland, 28th ed) Tablet
D013810 Therapeutic Equivalency The relative equivalency in the efficacy of different modes of treatment of a disease, most often used to compare the efficacy of different pharmaceuticals to treat a given disease. Bioequivalence,Clinical Equivalency,Equivalency, Therapeutic,Generic Equivalency,Clinical Equivalencies,Equivalencies, Clinical,Equivalencies, Therapeutic,Equivalency, Clinical,Therapeutic Equivalencies,Bioequivalences,Equivalencies, Generic,Equivalency, Generic,Generic Equivalencies
D018592 Cross-Over Studies Studies comparing two or more treatments or interventions in which the subjects or patients, upon completion of the course of one treatment, are switched to another. In the case of two treatments, A and B, half the subjects are randomly allocated to receive these in the order A, B and half to receive them in the order B, A. A criticism of this design is that effects of the first treatment may carry over into the period when the second is given. (Last, A Dictionary of Epidemiology, 2d ed) Cross-Over Design,Cross-Over Trials,Crossover Design,Crossover Studies,Crossover Trials,Cross Over Design,Cross Over Studies,Cross Over Trials,Cross-Over Designs,Cross-Over Study,Crossover Designs,Crossover Study,Design, Cross-Over,Design, Crossover,Designs, Cross-Over,Designs, Crossover,Studies, Cross-Over,Studies, Crossover,Study, Cross-Over,Study, Crossover,Trial, Cross-Over,Trial, Crossover,Trials, Cross-Over,Trials, Crossover
D019540 Area Under Curve A statistical means of summarizing information from a series of measurements on one individual. It is frequently used in clinical pharmacology where the AUC from serum levels can be interpreted as the total uptake of whatever has been administered. As a plot of the concentration of a drug against time, after a single dose of medicine, producing a standard shape curve, it is a means of comparing the bioavailability of the same drug made by different companies. (From Winslade, Dictionary of Clinical Research, 1992) AUC,Area Under Curves,Curve, Area Under,Curves, Area Under,Under Curve, Area,Under Curves, Area
D020156 Salicylic Acid A compound obtained from the bark of the white willow and wintergreen leaves. It has bacteriostatic, fungicidal, and keratolytic actions. 2-Hydroxybenzoic Acid,o-Hydroxybenzoic Acid,ortho-Hydroxybenzoic Acid,2 Hydroxybenzoic Acid,Acid, 2-Hydroxybenzoic,Acid, Salicylic,Acid, o-Hydroxybenzoic,Acid, ortho-Hydroxybenzoic,o Hydroxybenzoic Acid,ortho Hydroxybenzoic Acid

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