Document Detail


Effect of food on the bioavailability of gepirone in humans.
MedLine Citation:
PMID:  8103528     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
A randomized two-period crossover study was conducted in 20 healthy male volunteers to assess the effect of food on the pharmacokinetics of gepirone (BMY-13805) and its metabolite, 1-(2-pyrimidinyl)-piperazine (1-PP) after a single 20-mg dose of gepirone either after fasting or after consumption of a standard high-fat breakfast. There was a 1-week washout period between treatments. Plasma samples were obtained predose and at specified time points after dosing and analyzed for gepirone and 1-PP content by a specific gas chromatographic-mass spectrometric method. Food did not significantly affect gepirone maximum peak plasma concentration (Cmax) and half-life (t1/2). The mean gepirone Cmax was 16.98 +/- 8.12 ng/mL (fed) and 18.73 +/- 10.30 ng/mL (fasted), with mean t1/2 of 3.32 +/- 1.84 hours (fed) and 2.94 +/- 0.90 hours (fasted). Food significantly increased the mean area under the curveinf (AUCinf) from 55.26 +/- 35.74 ng.hour/mL (fasted) to 75.69 +/- 42.79 ng.hour/mL (fed), and the mean residence timeinf (MRTinf) from 4.31 +/- 0.78 hours (fasted) to 5.37 +/- 1.21 hours (fed). The median time to maximum plasma concentration (tmax) for gepirone was also significantly increased in the presence of food, 2.0 hours, versus 0.75 hours in the absence of food. For 1-PP, food had no affect on Cmax, t1/2, or AUCinf. Mean t1/2 for 1-PP in the presence and absence of food was 6.06 +/- 1.75 and 5.76 +/- 1.75 hours, respectively. MRTinf, however, was increased significantly from 9.32 +/- 2.68 hours (fasted) to 10.53 +/- 2.89 hours (fed).(ABSTRACT TRUNCATED AT 250 WORDS)
Authors:
L K Tay; M A Sciacca; M B Sostrin; R H Farmen; K A Pittman
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Journal of clinical pharmacology     Volume:  33     ISSN:  0091-2700     ISO Abbreviation:  J Clin Pharmacol     Publication Date:  1993 Jul 
Date Detail:
Created Date:  1993-10-07     Completed Date:  1993-10-07     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  0366372     Medline TA:  J Clin Pharmacol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  631-5     Citation Subset:  IM    
Affiliation:
Department of Metabolism and Pharmacokinetics, Bristol-Myers Squibb Co., Syracuse, New York 13221-4755.
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Adolescent
Adult
Anti-Anxiety Agents / pharmacokinetics*
Antidepressive Agents / pharmacokinetics*
Biological Availability
Buspirone / analogs & derivatives,  blood,  pharmacokinetics
Fasting / blood
Food*
Humans
Male
Pyrimidines / administration & dosage,  blood,  pharmacokinetics*
Chemical
Reg. No./Substance:
0/Anti-Anxiety Agents; 0/Antidepressive Agents; 0/Pyrimidines; 20980-22-7/1-(2-pyrimidinyl)piperazine; 36505-84-7/Buspirone; 83928-76-1/gepirone

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


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