生物等效性和生物利用度杂志

抽象的

Bioequivalence Study of Two Formulations Containing Irbesartan 300 Mg Tablets in Healthy Colombian Volunteers

Vargas M, Bustamante C and Villarraga Ea

This is a pharmacokinetic study of two formulations containing Irbesartan 300 mg. Its objective was to compare the Bioavailability between the Test product (Irbesartan produced by Tecnoquímicas S.A., Colombia laboratory) and the Reference product (Aprovel® produced by Sanofi Aventis laboratory) in order to be able to state the Bioequivalence between them. For this, an open label, two periods, two randomized sequences, crossover, single fasting 300 mg dose study was performed with an 8-day washout period between each period in 24 healthy volunteers and collection of 12 plasma samples between 0 and 48 hours. The analytical method used was HPLC. The 90% confidence interval for the Cmax parameter was between 83.0 – 113.9 with a 97.2 ratio; for the AUC0-t parameter the 90% CI it is between 92.1 -116.7 with a 103.7 ratio, and for the AUC0-∞ the 90% CI was found to be between 95.5 – 114.8 with a 104.7 ratio. According to the European and FDA guidelines, the confidence interval falls within the permissible ranges for Bioequivalence and Interchangeability declaration of the Tecnoquímicas S.A. product with the Sanofi Aventis Reference product, Aprovel®