Pharmacokinetic and bioequivalence testing of atorvastatin formulations in healthy male volunteers. 2006

L Mendoza, and M Hajdúch, and R Plausinaitis, and V Platílová, and N Emritte, and M Svoboda
IQA, as, Prague, Czech Republic. mendoza@iqa.cz

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.

UI MeSH Term Description Entries
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D011758 Pyrroles Azoles of one NITROGEN and two double bonds that have aromatic chemical properties. Pyrrole
D002626 Chemistry, Pharmaceutical Chemistry dealing with the composition and preparation of agents having PHARMACOLOGIC ACTIONS or diagnostic use. Medicinal Chemistry,Chemistry, Pharmaceutic,Pharmaceutic Chemistry,Pharmaceutical Chemistry,Chemistry, Medicinal
D002851 Chromatography, High Pressure Liquid Liquid chromatographic techniques which feature high inlet pressures, high sensitivity, and high speed. Chromatography, High Performance Liquid,Chromatography, High Speed Liquid,Chromatography, Liquid, High Pressure,HPLC,High Performance Liquid Chromatography,High-Performance Liquid Chromatography,UPLC,Ultra Performance Liquid Chromatography,Chromatography, High-Performance Liquid,High-Performance Liquid Chromatographies,Liquid Chromatography, High-Performance
D006538 Heptanoic Acids 7-carbon saturated monocarboxylic acids. Acids, Heptanoic
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000069059 Atorvastatin A pyrrole and heptanoic acid derivative, HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITOR (statin), and ANTICHOLESTEREMIC AGENT that is used to reduce serum levels of LDL-CHOLESTEROL; APOLIPOPROTEIN B; and TRIGLYCERIDES. It is used to increase serum levels of HDL-CHOLESTEROL in the treatment of HYPERLIPIDEMIAS, and for the prevention of CARDIOVASCULAR DISEASES in patients with multiple risk factors. (3R,5R)-7-(2-(4-Fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoic acid,Atorvastatin Calcium,Atorvastatin Calcium Anhydrous,Atorvastatin Calcium Hydrate,Atorvastatin Calcium Trihydrate,Atorvastatin, Calcium Salt,CI 981,CI-981,Lipitor,Liptonorm,CI981
D000293 Adolescent A person 13 to 18 years of age. Adolescence,Youth,Adolescents,Adolescents, Female,Adolescents, Male,Teenagers,Teens,Adolescent, Female,Adolescent, Male,Female Adolescent,Female Adolescents,Male Adolescent,Male Adolescents,Teen,Teenager,Youths
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults

Related Publications

L Mendoza, and M Hajdúch, and R Plausinaitis, and V Platílová, and N Emritte, and M Svoboda
September 2014, International journal of clinical pharmacology and therapeutics,
L Mendoza, and M Hajdúch, and R Plausinaitis, and V Platílová, and N Emritte, and M Svoboda
September 2016, Clinical drug investigation,
L Mendoza, and M Hajdúch, and R Plausinaitis, and V Platílová, and N Emritte, and M Svoboda
January 1996, European journal of clinical pharmacology,
L Mendoza, and M Hajdúch, and R Plausinaitis, and V Platílová, and N Emritte, and M Svoboda
March 2012, Zhonghua xin xue guan bing za zhi,
L Mendoza, and M Hajdúch, and R Plausinaitis, and V Platílová, and N Emritte, and M Svoboda
January 2018, Drug design, development and therapy,
L Mendoza, and M Hajdúch, and R Plausinaitis, and V Platílová, and N Emritte, and M Svoboda
November 2016, International journal of clinical pharmacology and therapeutics,
L Mendoza, and M Hajdúch, and R Plausinaitis, and V Platílová, and N Emritte, and M Svoboda
April 2005, Biopharmaceutics & drug disposition,
L Mendoza, and M Hajdúch, and R Plausinaitis, and V Platílová, and N Emritte, and M Svoboda
December 2009, International journal of clinical pharmacology and therapeutics,
L Mendoza, and M Hajdúch, and R Plausinaitis, and V Platílová, and N Emritte, and M Svoboda
January 2008, Arzneimittel-Forschung,
L Mendoza, and M Hajdúch, and R Plausinaitis, and V Platílová, and N Emritte, and M Svoboda
July 2003, Drug development and industrial pharmacy,
Copied contents to your clipboard!