Document Detail


Effects of food, antacid, and dosage form on the pharmacokinetics and relative bioavailability of sertindole in healthy volunteers.
MedLine Citation:
PMID:  9267685     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The pharmacokinetic disposition and relative bioavailability of sertindole administered as a tablet dosage form under fasting conditions, in the presence of food, in the presence of antacid, and as solution was studied in a four-way crossover in young healthy male volunteers. Overall, tablet dosing after a meal or Maalox had no effect on t1/2 or AUC values when compared to fasting conditions, but increased the tmax and decreased the Cmax values slightly. The mean relative bioavailabilities of sertindole administered as tablets after fasting, with food, and with Maalox are 99, 104, and 98%, respectively, compared to sertindole solution. Therefore, sertindole can be administered with and without food and without regard to coadministration of antacids.
Authors:
S L Wong; P Linnen; R Mack; G R Granneman
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Biopharmaceutics & drug disposition     Volume:  18     ISSN:  0142-2782     ISO Abbreviation:  Biopharm Drug Dispos     Publication Date:  1997 Aug 
Date Detail:
Created Date:  1997-10-02     Completed Date:  1997-10-02     Revised Date:  2009-11-02    
Medline Journal Info:
Nlm Unique ID:  7911226     Medline TA:  Biopharm Drug Dispos     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  533-41     Citation Subset:  IM    
Affiliation:
Department of Pharmacokinetics and Biopharmaceutics, Abbott Laboratories, Abbott Park, IL 60064-3500, USA. shekman.wong@abott.com
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Adult
Aluminum Hydroxide / pharmacology*
Analysis of Variance
Antacids / pharmacology*
Antipsychotic Agents / administration & dosage,  blood,  pharmacokinetics*
Area Under Curve
Biological Availability
Cross-Over Studies
Drug Combinations
Fasting / blood
Food-Drug Interactions*
Humans
Imidazoles / administration & dosage,  blood,  pharmacokinetics*
Indoles / administration & dosage,  blood,  pharmacokinetics*
Magnesium Hydroxide / pharmacology*
Male
Solutions
Tablets
Chemical
Reg. No./Substance:
0/Antacids; 0/Antipsychotic Agents; 0/Drug Combinations; 0/Imidazoles; 0/Indoles; 0/Solutions; 0/Tablets; 106516-24-9/sertindole; 1309-42-8/Magnesium Hydroxide; 21645-51-2/Aluminum Hydroxide; 37317-08-1/aluminum hydroxide, magnesium hydroxide, drug combination

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


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