DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Bioequivalence evaluation of two brands of lisinopril tablets (Lisotec and Zestril) in healthy human volunteers.

Author(s): Tamimi JJ, Salem II, Alam SM, Zaman Q, Dham R

Affiliation(s): ACDIMA Center for Bioequivalence and Pharmaceutical Studies, Amman, Jordan.

Publication date & source: 2005-11, Biopharm Drug Dispos., 26(8):335-9.

Publication type: Clinical Trial; Randomized Controlled Trial

The bioequivalence of two brands of lisinopril 20 mg tablets was demonstrated in 28 healthy human volunteers after a single oral dose in a randomized cross-over study, conducted at ACDIMA Center for Bioequivalence and Pharmaceutical Studies, Amman, Jordan. Reference (Zestril, AstraZeneca, UK) and test (Lisotec, Julphar, UAE) products were administered to fasting volunteers on 2 treatment days separated by a 2-week washout period; blood samples were collected at specified time intervals, and the plasma was separated and analysed for lisinopril using a validated LC-MS/MS method at ACDIMA Laboratory. The pharmacokinetic parameters AUC(0-t), AUC(0- proportional), C(MAX), T(MAX), T(1/2) and the elimination rate constant were determined from the plasma concentration-time profiles for both formulations and were compared statistically to evaluate bioequivalence between the two brands, using the statistical modules recommended by the FDA. The analysis of variance (ANOVA) did not show any significant difference between the two formulations and 90% confidence intervals fell within the acceptable range for bioequivalence. Based on these statistical inferences it was concluded that the two brands exhibited comparable pharmacokinetic profiles and that Julphar's Lisotec is bioequivalent to Zestril of AstraZeneca, UK. Copyright (c) 2005 John Wiley & Sons, Ltd.

Page last updated: 2006-01-31

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017