Pharmacokinetic and bioequivalence testing of atorvastatin formulations in healthy male volunteers.
The aim of this study was to compare the bioavailability of two atorvastatin formulations (Divator Drogsan Pharmaceuticals, Ankara, Turkey, as the test formulation, and Lipitor, Pfizer Ireland Pharmaceuticals, Dublin, Ireland, as the reference formulation) in 52 healthy volunteers. The study was conducted using a randomised, single-dose, two-way crossover study with a 2-week washout period between the doses. Since the 90% confidence intervals for Cmax, AUC0-72 and AUC0-proprtional to ratios for both, the parent atorvastatin and its main active metabolite ortho-hydroxy atorvastatin, were within the pre-defined Bioequivalance acceptance limits approved by EMEA, we concluded that the atorvastatin formulation elaborated by Drogsan Pharmaceuticals, was bioequivalent to the Lipitor in its rate and extent of absorption.
Mendoza
L
L
IQA, as, Prague, Czech Republic. mendoza@iqa.cz
Hajdúch
M
M
Plausinaitis
R
R
Platílová
V
V
Emritte
N
N
Svoboda
M
M
D000293:Adolescent; D000328:Adult; D019540:Area Under Curve; D000069059:Atorvastatin; D001711:Biotransformation; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D006538:Heptanoic Acids / Q000008:administration & dosage* / Q000737:chemistry / Q000493:pharmacokinetics*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage* / Q000737:chemistry / Q000493:pharmacokinetics*; D008297:Male; D013058:Mass Spectrometry; D008875:Middle Aged; D011758:Pyrroles / Q000008:administration & dosage* / Q000737:chemistry / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency
D006538:Heptanoic Acids; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011758:Pyrroles; D000069059:Atorvastatin