Document Detail


Comparative pharmacokinetics of lovastatin extended-release tablets and lovastatin immediate-release tablets in humans.
MedLine Citation:
PMID:  11831543     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The pharmacokinetics of lovastatin and its active metabolite lovastatin acid was evaluated in 9 healthy subjects in a three-period crossover study following a single oral dose of lovastatin extended-release (ER) tablets and lovastatin immediate-release (IR) tablets. Participants were dosed with lovastatin IR 40 mg tablets following a standard breakfast, lovastatin ER 40 mg tablets following a standard breakfast, and lovastatin ER 40 mg tablets underfasting conditions. Serial plasma samples were collected for up to 48 hours postdose and assayed for lovastatin and lovastatin acid using a liquid chromatography/mass spectroscopy/mass spectroscopy method. Lovastatin ER tablets, unlike lovastatin IR tablets, exhibited delayed- and extended-release characteristics. The relative bioavailability, in terms of area under the curve values, of lovastatin (156%) and lovastatin acid (124%) was greater from lovastatin ER tablets as compared with lovastatin IR tablets when given with breakfast. An even greater increase in the bioavailability of lovastatin (261%) and lovastatin acid (231%) was observed when the lovastatin ER tablets were administered under fasting conditions. Thus, greater gastrointestinal tract drug absorption of lovastatin from lovastatin ER tablets was demonstrated. Ingestion of a standard breakfast prior to administration of lovastatin ER tablets decreased absorption of lovastatin by approximately 40%, relative to lovastatin ER tablets under fasting conditions.
Authors:
Jim X Sun; Robert Niecestro; Gale Phillips; Jason Shen; Peter Lukacsko; Lawrence Friedhoff
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of clinical pharmacology     Volume:  42     ISSN:  0091-2700     ISO Abbreviation:  J Clin Pharmacol     Publication Date:  2002 Feb 
Date Detail:
Created Date:  2002-02-07     Completed Date:  2002-07-23     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0366372     Medline TA:  J Clin Pharmacol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  198-204     Citation Subset:  IM    
Affiliation:
Department of Clinical Research, Andrx Laboratories, Inc., Andrx Corporation, Fort Lauderdale, Florida, USA.
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MeSH Terms
Descriptor/Qualifier:
Adult
Anticholesteremic Agents / administration & dosage,  pharmacokinetics*
Area Under Curve
Cross-Over Studies
Delayed-Action Preparations
Food-Drug Interactions
Half-Life
Humans
Lovastatin / administration & dosage,  pharmacokinetics*
Male
Single-Blind Method
Chemical
Reg. No./Substance:
0/Anticholesteremic Agents; 0/Delayed-Action Preparations; 75330-75-5/Lovastatin

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


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