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Comparative pharmacokinetics of two tablet formulations of Losartan: bioequivalence assessment
Author(s) -
Tamimi J.J.I.,
Salem I.I.,
Mahmood Alam S.,
Zaman Q.,
Dham Ruwayda
Publication year - 2005
Publication title -
biopharmaceutics and drug disposition
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.419
H-Index - 58
eISSN - 1099-081X
pISSN - 0142-2782
DOI - 10.1002/bdd.448
Subject(s) - bioequivalence , pharmacokinetics , losartan , confidence interval , pharmacology , medicine , chromatography , analysis of variance , metabolite , active metabolite , elimination rate constant , chemistry , angiotensin ii , volume of distribution , blood pressure
The pharmacokinetic profiles of two brands of losartan 50 mg tablets were compared in 24 healthy adult volunteers after a single oral dose in a randomized cross‐over study. The study was conducted at the ACDIMA Center for Bioequivalence & Pharmaceutical Studies, Amman, Jordan. The reference (Cozaar, MSD, The Netherlands) and test (Blosart, Julphar, UAE) products were administered to fasting volunteers. Blood samples were collected at specified time intervals, and the plasma separated and analysed for losartan and its active metabolite (losartan carboxylic acid) using a validated HPLC method with fluorescence detection. Pharmacokinetic parameters AUC 0−t , AUC 0−α , C max , T max , T 1/2 , elimination rate constant, MRT , C l/ F and V ss/ F were determined from plasma concentration‐time profiles of both formulations and found to be in good agreement with reported values. Three parameters ( AUC 0−t , AUC 0−α , and C max ) were compared statistically to evaluate the bioequivalence between the two brands, using statistical modules recommended by the FDA. Analysis of variance (ANOVA) did not show any significant difference between the two formulations and 90% confidence intervals fell within the acceptable range (80%–125%) for bioequivalence. Based on these statistical inferences it was concluded that the two formulations exhibited comparable pharmacokinetic profiles and that Julphar's Blosart is bioequivalent to Cozaar of MSD, The Netherlands. Copyright © 2005 John Wiley & Sons, Ltd.