Document Detail


Food does not affect the pharmacokinetics of tesaglitazar, a novel dual peroxisome proliferator-activated receptor alpha/gamma agonist.
MedLine Citation:
PMID:  16920896     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Tesaglitazar is a dual peroxisome proliferator-activated receptor (PPAR) alpha/gamma agonist in development to treat lipid and glucose abnormalities associated with type 2 diabetes. This study evaluated the effects of food on tesaglitazar pharmacokinetics. In an open, randomized, 2-way crossover study, 20 healthy men received tesaglitazar 1 mg during fasting and after a high-fat, high-calorie breakfast. Blood samples were taken to assess pharmacokinetic variables. Systemic exposure to tesaglitazar was unaffected by food intake. Estimated ratios were 0.99 (90% confidence interval [CI], 0.94-1.04) for fed/fasted area under plasma concentration-time curve and 0.82 (90% CI, 0.78-0.86) for fed/fasted maximum plasma concentration (C(max)). Mean C(max) was approximately 18% lower (0.41 [95% CI, 0.38-0.43] versus 0.50 [95% CI, 0.47-0.53] mumol/L), and median time to C(max) was increased (2.00 vs 0.75 h) in fed versus fasted state. The median difference of t(max) was 1.25 h (P = .0001, signed-rank test). Tesaglitazar was well tolerated. Tesaglitazar pharmacokinetics is unaffected by food intake, allowing once-daily administration of tesaglitazar with or without food in clinical practice.
Authors:
S Samuelsson; S Johansson; S Halldórsdóttir; H Stenhoff; K P Ohman
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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 Sep 
Date Detail:
Created Date:  2006-08-21     Completed Date:  2006-12-22     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0366372     Medline TA:  J Clin Pharmacol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1017-22     Citation Subset:  IM    
Affiliation:
AstraZeneca R&D Mölndal, Mölndal, Sweden.
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MeSH Terms
Descriptor/Qualifier:
Adult
Alkanesulfonates / adverse effects,  blood,  pharmacokinetics*
Food*
Health
Humans
Male
Middle Aged
PPAR alpha / agonists*
PPAR gamma / agonists*
Phenylpropionates / adverse effects,  blood,  pharmacokinetics*
Chemical
Reg. No./Substance:
0/2-ethoxy-3-(4-((4-(methylsulfonyloxy)phenethyl)oxy)phenyl)propanoic acid; 0/Alkanesulfonates; 0/PPAR alpha; 0/PPAR gamma; 0/Phenylpropionates

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