Document Detail

Lack of effect of orlistat on the bioavailability of a single dose of nifedipine extended-release tablets (Procardia XL) in healthy volunteers.
MedLine Citation:
PMID:  8728349     Owner:  NLM     Status:  MEDLINE    
Orlistat, a lipase inhibitor, reduces dietary fat absorption, and thus could potentially alter the absorption of some concomitantly administered drugs, such as the nifedipine gastrointestinal therapeutic system (GITS). To assess the effect of orlistat on the bioavailability of nifedipine GITS, a third party-blind, placebo-controlled, randomized, two-way crossover study was performed in 18 healthy volunteers. Each participant received single 60-mg oral doses of nifedipine GITS (Procardia XL; Pfizer Labs, New York, NY) on the fourth day of treatment with 120 mg of orlistat or placebo three times a day for 6 days. The two treatments were separated by a washout period of at least 1 week. Serial blood samples were collected before and at appropriate intervals after each nifedipine dose to determine plasma concentrations of nifedipine. The 90% confidence intervals for the ratio of geometric least-square means for maximum concentration (C(max)) and area under the concentration-time curve (AUCo-t) and for the difference of arithmetic least-square means for time to maximum concentration (t(max)) indicate that the bioavailability of nifedipine was not altered by treatment with orlistat. Therapeutic doses of 120 mg of orlistat three times daily do not significantly alter the bioavailability of a single 60-mg oral dose of nifedipine GITS in healthy volunteers.
A T Melia; T E Mulligan; J Zhi
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Journal of clinical pharmacology     Volume:  36     ISSN:  0091-2700     ISO Abbreviation:  J Clin Pharmacol     Publication Date:  1996 Apr 
Date Detail:
Created Date:  1996-09-30     Completed Date:  1996-09-30     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:  352-5     Citation Subset:  IM    
Hoffmann-La Roche, Inc., Nutley, New Jersey 07110-1199, USA.
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MeSH Terms
Administration, Oral
Analysis of Variance
Biological Availability
Calcium Channel Blockers / administration & dosage,  blood,  pharmacokinetics*
Cross-Over Studies
Delayed-Action Preparations
Drug Interactions
Enzyme Inhibitors / pharmacology*
Hypertension / metabolism
Lactones / pharmacology*
Middle Aged
Nifedipine / administration & dosage,  blood,  pharmacokinetics*
Reg. No./Substance:
0/Calcium Channel Blockers; 0/Delayed-Action Preparations; 0/Enzyme Inhibitors; 0/Lactones; 21829-25-4/Nifedipine; 96829-58-2/orlistat

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

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