Document Detail


Comparative bioavailability study with two amiodarone tablet formulations administered with and without food in healthy subjects.
MedLine Citation:
PMID:  17966757     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: The aim was to assess the comparative bioavailability of two formulations (200 mg tablet) of amiodarone (CAS 19774-82-4) in healthy volunteers of both sexes, with and without food. METHODS: The study was conducted using an open, randomized, two-period crossover design with a 3-week washout interval, in two groups, with and without food. Plasma samples were obtained for up to 240 h post dose. Plasma amiodarone concentrations were analyzed by liquid chromatography coupled to tandem mass spectrometry (LC-MS-MS) with positive ion electrospray ionization using multiple reactions monitoring (MRM). From the amiodarone plasma concentration vs. time curves, the following pharmacokinetic parameters were obtained, with and without food: AUC(last), AUC(inf), AUC(0-240h), AUC(0-72h) and C(max). RESULTS: The limit of quantification was 1 ng/mL for plasma amiodarone analysis. The geometric mean and 90% confidence interval CI of Test/Reference percent ratios were, without and with food, respectively: 107.61 (92.73-124.89) and 100.6 (94.1-107.5) for C(max), 107.05 (95.88-119.51) and 100.2 (96.0-104.7) for AUC(last), 107.27 (95.78-120.15) and 100.8 (97.0-104.8) for AUC(0-72h), 106.76 (95.84-118.94) and 100.2 (96.0-104.7) for AUC(0-240h) and AUC(inf) 105.15 (94.18-117.41) and 100.7 (96.6-105.0). CONCLUSION: Since the 90% CI for AUC(0-72) and C(max) ratios were within the 80-125% interval proposed by the US FDA, it was concluded that the amiodarone 200 mg tablet (test formulation) with and without food was bioequivalent to the reference 200 mg tablet for both the rate and extent of absorption.
Authors:
Hilton Oliveira dos Santos Filho; Jaime O Ilha; Lara Cristina Silva; André Borges; Gustavo D Mendes; Gilberto De Nucci
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Arzneimittel-Forschung     Volume:  57     ISSN:  0004-4172     ISO Abbreviation:  Arzneimittelforschung     Publication Date:  2007  
Date Detail:
Created Date:  2007-10-29     Completed Date:  2007-12-06     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0372660     Medline TA:  Arzneimittelforschung     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  582-90     Citation Subset:  IM    
Affiliation:
Cartesius Analytical Unit, Department of Pharmacology, Institute of Biomedical Sciences, University of São Paulo, São Paulo, SP, Brazil.
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MeSH Terms
Descriptor/Qualifier:
Adult
Amiodarone / administration & dosage*,  blood,  pharmacokinetics*
Anti-Arrhythmia Agents / administration & dosage*,  blood,  pharmacokinetics*
Area Under Curve
Biological Availability
Chemistry, Pharmaceutical
Chromatography, Liquid
Cross-Over Studies
Female
Food
Humans
Intestinal Absorption
Male
Spectrometry, Mass, Electrospray Ionization
Tablets
Tandem Mass Spectrometry
Chemical
Reg. No./Substance:
0/Anti-Arrhythmia Agents; 0/Tablets; 1951-25-3/Amiodarone

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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