Document Detail


Effects of a Protein-Rich Drink or a Standard Meal on the Pharmacokinetics of Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir in Healthy Japanese Male Subjects: A Randomized, Three-Way Crossover Study.
MedLine Citation:
PMID:  24615728     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
This study investigated the effects of ingested food types on the pharmacokinetics of elvitegravir, cobicistat, emtricitabine, and tenofovir as a single-tablet regimen (STR) in Japanese HIV-negative healthy subjects. In this open-label, randomized, three-way crossover study, the pharmacokinetic profiles of elvitegravir, cobicistat, emtricitabine, and tenofovir were evaluated when administered with a standard breakfast, under fasting conditions, or with a nutritional protein-rich drink. All subjects (N = 11) received a single morning dose of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (150/150/200/300 mg). Administration under fasting conditions resulted in decreases in the mean AUCinf of elvitegravir and tenofovir by 50% and 28%, respectively, relative to administration with a standard breakfast, whereas the bioavailabilities of elvitegravir and tenofovir were comparable when administered with a standard breakfast or a nutritional protein-rich drink. Under fasting conditions, it appears that the bioavailabilities of elvitegravir and tenofovir were not equivalent to those when they were administered with either type of food, although they were bioequivalent to each other under fed conditions. Cobicistat and emtricitabine were bioequivalent under all conditions. These findings suggest that elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate should be administered with food, and that the bioavailability of elvitegravir and tenofovir is not affected by the type of meal ingested.
Authors:
Mari Shiomi; Shunji Matsuki; Atsushi Ikeda; Tomohiro Ishikawa; Noriaki Nishino; Miyuki Kimura; Shin Irie
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2014-3-11
Journal Detail:
Title:  Journal of clinical pharmacology     Volume:  -     ISSN:  1552-4604     ISO Abbreviation:  J Clin Pharmacol     Publication Date:  2014 Mar 
Date Detail:
Created Date:  2014-3-11     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0366372     Medline TA:  J Clin Pharmacol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
© 2014, The American College of Clinical Pharmacology.
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