%0 Journal Article
%A Vargas M.
%A Bustamante C.
%A Villarraga EA.
%8 2015
%U http://hdl.handle.net/10818/37543
%X 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.
%I Journal of J Bioequivalence & Bioavailability
%K Bioequivalence
%K Irbesartan
%K Antihypertensive
%K Pharmacokinetics
%T Bioequivalence Study of Two Formulations Containing Irbesartan 300 Mg Tablets in Healthy Colombian Volunteers
%R 10.4172/jbb.1000237
%~ Intellectum