Document Detail

Absence of food effect on the pharmacokinetics of telbivudine following oral administration in healthy subjects.
MedLine Citation:
PMID:  16490803     Owner:  NLM     Status:  MEDLINE    
The influence of food on the pharmacokinetics of telbivudine, a candidate antiviral agent against hepatitis B virus (HBV), was investigated in healthy adult subjects following a 600-mg oral dose administered with and without a high-fat/high-calorie meal. Telbivudine was well tolerated under fasting and fed conditions. Oral absorption of telbivudine as measured by maximum plasma concentration (Cmax), time to reach Cmax (Tmax), and area under the plasma concentration-time curve (AUC(0-t) and AUC(0-infinity)) was not altered by food intake immediately before oral dosing. Values of Cmax, Tmax, and AUC were comparable when telbivudine was administered under fed and fasting conditions. Results from this study indicated that the absorption of telbivudine was not affected by a high-fat/high-calorie meal; telbivudine can therefore be administered orally with no regard to the timing of meals.
Xiao-Jian Zhou; Deborah M Lloyd; George C Chao; Nathaniel A Brown
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Journal of clinical pharmacology     Volume:  46     ISSN:  0091-2700     ISO Abbreviation:  J Clin Pharmacol     Publication Date:  2006 Mar 
Date Detail:
Created Date:  2006-02-21     Completed Date:  2006-07-06     Revised Date:  2013-08-26    
Medline Journal Info:
Nlm Unique ID:  0366372     Medline TA:  J Clin Pharmacol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  275-81     Citation Subset:  IM    
Idenix Pharmaceuticals Inc, 60 Hampshire Street, Cambridge, MA 02139, USA.
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MeSH Terms
Administration, Oral
Antiviral Agents / administration & dosage,  blood,  pharmacokinetics*
Area Under Curve
Cross-Over Studies
Dietary Fats / pharmacology
Drug Monitoring
Energy Intake
Food-Drug Interactions*
Nucleosides / administration & dosage,  blood,  pharmacokinetics*
Pyrimidinones / administration & dosage,  blood,  pharmacokinetics*
Reg. No./Substance:
0/Antiviral Agents; 0/Dietary Fats; 0/Nucleosides; 0/Pyrimidinones; 2OC4HKD3SF/telbivudine

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