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Pharmacokinetic and bioequivalence testing of atorvastatin formulations in healthy male volunteers
Mendoza L, Hajdúch M, Plausinaitis R, Platílová V, Emritte N, Svoboda M.
Language English Country Germany
Document type Comparative Study, Randomized Controlled Trial
NLK
Freely Accessible Science Journals
from 2003 to 1 year ago
- MeSH
- Biotransformation MeSH
- Adult MeSH
- Chemistry, Pharmaceutical MeSH
- Financing, Organized MeSH
- Mass Spectrometry MeSH
- Cross-Over Studies MeSH
- Heptanoic Acids administration & dosage pharmacokinetics chemistry MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Area Under Curve MeSH
- Pyrroles administration & dosage pharmacokinetics chemistry MeSH
- Hydroxymethylglutaryl-CoA Reductase Inhibitors administration & dosage pharmacokinetics chemistry MeSH
- Therapeutic Equivalency MeSH
- Chromatography, High Pressure Liquid MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Male MeSH
- Publication type
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
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.
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