Document Detail


The effect of different meal types on the pharmacokinetics of darunavir (TMC114)/ritonavir in HIV-negative healthy volunteers.
MedLine Citation:
PMID:  17389557     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
This open-label, randomized, crossover study investigated the bioavailability, short-term safety, and tolerability of darunavir (TMC114) coadministered with low-dose ritonavir under fasted conditions and after different meal types in HIV-negative healthy volunteers. All volunteers received ritonavir 100 mg twice daily on days 1 to 5, with a single darunavir 400-mg tablet given on day 3 (darunavir/rtv). Pharmacokinetic parameters for darunavir and ritonavir were determined under fasted conditions and following a standard breakfast, a high-fat breakfast, a nutritional protein-rich drink, or a croissant with coffee. Administration of darunavir/rtv in a fasting state resulted in a decrease in darunavir C(max) and AUC(last) of approximately 30% compared with administration after a standard meal. No significant differences in darunavir plasma concentrations were observed between different fed states. Darunavir/rtv should therefore be administered with food, but exposure to darunavir is not affected by the type of meal.
Authors:
Vanitha Sekar; Dries Kestens; Sabrina Spinosa-Guzman; Martine De Pauw; Els De Paepe; Tony Vangeneugden; Eric Lefebvre; Richard M W Hoetelmans
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of clinical pharmacology     Volume:  47     ISSN:  0091-2700     ISO Abbreviation:  J Clin Pharmacol     Publication Date:  2007 Apr 
Date Detail:
Created Date:  2007-03-28     Completed Date:  2007-06-05     Revised Date:  2013-06-03    
Medline Journal Info:
Nlm Unique ID:  0366372     Medline TA:  J Clin Pharmacol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  479-84     Citation Subset:  IM    
Affiliation:
Tibotec, Inc, Yardley, Pennsylvania, USA.
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Area Under Curve
Cross-Over Studies
Drug Combinations
Fasting
Female
Food-Drug Interactions*
HIV Protease Inhibitors / administration & dosage,  adverse effects,  pharmacokinetics*
HIV Seronegativity
Half-Life
Humans
Male
Middle Aged
Ritonavir / administration & dosage,  adverse effects,  pharmacokinetics*
Sulfonamides / administration & dosage,  adverse effects,  pharmacokinetics*
Chemical
Reg. No./Substance:
0/Drug Combinations; 0/HIV Protease Inhibitors; 0/Ritonavir; 0/Sulfonamides; YO603Y8113/darunavir

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


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