Bioequivalence evaluation of two different tablet formulations of tinidazole in healthy volunteers.
The bioequivalence of two different tablet formulations of tinidazole (CAS 19387-91-8) was determined in healthy volunteers after a single dose in a randomized crossover study, with a 1-week washout period between the doses. Reference and test products were administered to 24 volunteers with 240 mL water after overnight fasting. Plasma concentrations of tinidazole were monitored by a high-performance liquid chromatographic method (HPLC) over a period of 72 h after the administration. The pharmacokinetic parameters AUC(o-t), AUCo-infinity, C(max), T(max), T((1/2)el) and beta were determined from plasma concentration time profile of both formulations and found to be in good agreement with previously reported values. The calculated pharmacokinetic parameters were compared statistically to evaluate bioequivalence between the two brands. The analysis of variance (ANOVA) did not show any significant difference between the two formulations and 90% confidence intervals for the ratio of C(max) (93.9 -102.6%), AUC(o-t) (94.9-101.1%) and AUC(o-infinity) (94.6-100.8%) values for the test and reference products were within the 80-125% interval, satisfying the bioequivalence criteria of the European Committee for Proprietary Medicinal Products and the US Food and Drug Administration Guidelines. These results Indicate that the test and the reference products of tinidazole are bioequivalent and, thus, may be prescribed interchangeably.
Koono
Eunice Emiko Mori
EE
Departamento de Farmácia, Faculdade de Ciências Farmacêuticas, Universidade de São Paulo, São Paulo, SP, Brazil.
Kano
Eunice Kazue
EK
Schramm
Simone Grigoleto
SG
dos Reis Serra
Cristina Helena
CH
Porta
Valentina
V
D000328:Adult; D000994:Antitrichomonal Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D005260:Female; D006207:Half-Life; D006801:Humans; D008297:Male; D013607:Tablets; D013810:Therapeutic Equivalency; D014011:Tinidazole / Q000008:administration & dosage / Q000493:pharmacokinetics*; D055815:Young Adult
D000994:Antitrichomonal Agents; D013607:Tablets; D014011:Tinidazole