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Pharmacokinetics and bioequivalence evaluation of two simvastatin 40 mg tablets ( Simvast & Zocor ) in healthy human volunteers
Author(s) -
Najib Naji M.,
Idkaidek Nasir,
Adel Ayman,
Admour Isra',
Astigarraga Rafel E. B.,
Nucci Gliberto De,
Alam S. Mahmood,
Dham Ruwayda
Publication year - 2003
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.347
Subject(s) - bioequivalence , pharmacokinetics , simvastatin , confidence interval , analysis of variance , medicine , pharmacology , elimination rate constant , metabolite , active metabolite , volume of distribution
The pharmacokinetics of two brands of simvastatin 40 mg tablets were compared in 24 healthy human volunteers after a single oral dose in a randomized cross‐over study, conducted at IPRC, Amman, Jordan. Reference ( Zocor , MSD, Netherlands) and test ( Simvast , Julphar, UAE) products were administered to fasted volunteers; blood samples were collected at specified time intervals, plasma separated and analyzed for simvastatin and its active metabolite ( β ‐hydoxy acid) using a validated LC–MS/MS method at Cartesius Analytical Unit, Institute of Biomedical Sciences – USP, Sao Paulo, Brazil. The pharmacokinetic parameters AUC 0−t , AUC 0−∝ , C MAX , T MAX , T 1/2 and elimination rate constant were determined from plasma concentration–time profile for both formulations and were compared statistically to evaluate bioequivalence between the two brands, using the statistical modules recommended by 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 Simvast is bioequivalent to Zocor of MSD, Netherlands. Copyright © 2003 John Wiley & Sons, Ltd.