Comparative pharmacokinetics of two tablet formulations of Losartan: bioequivalence assessment.
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-alpha), C(max), T(max), T(1/2), elimination rate constant, MRT, Cl/F and Vss/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-alpha), 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.
Tamimi
J J I
JJ
ACDIMA Center for Bioequivalence & Pharmaceutical Studies, Amman, Jordan.
Salem
I I
II
Mahmood Alam
S
S
Zaman
Q
Q
Dham
Ruwayda
R
D000328:Adult; D000704:Analysis of Variance; D000959:Antihypertensive Agents / Q000097:blood / Q000378:metabolism / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002626:Chemistry, Pharmaceutical; D018592:Cross-Over Studies; D006207:Half-Life; D006801:Humans; D007597:Jordan; D019808:Losartan / Q000097:blood / Q000378:metabolism / Q000493:pharmacokinetics*; D008297:Male; D013607:Tablets; D013810:Therapeutic Equivalency
D000959:Antihypertensive Agents; D013607:Tablets; D019808:Losartan