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rdf:type |
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lifeskim:mentions |
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pubmed:issue |
10
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pubmed:dateCreated |
2006-9-21
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pubmed:abstractText |
The effects of omeprazole and lansoprazole (CYP3A4 inhibitors) on the pharmacokinetics of a single dose of ivabradine (metabolized via CYP3A4) and its active metabolite (S18982) were assessed. Pharmacodynamics and safety were secondary objectives. An open-label, randomized, crossover, phase I, pharmacokinetic interaction design was used. Volunteers received a single oral dose of ivabradine (10 mg), were randomized to receive either omeprazole (40 mg) or lansoprazole (60 mg) for 5 days, and were administered an ivabradine dose on the sixth day. Crossover was performed after washout. Pharmacokinetic parameters for ivabradine did not vary significantly after omeprazole (C(max): 45.0 +/- 36.6 vs 42.7 +/- 27.6 ng/mL, P = .98; AUC: 128 +/- 87 vs 126 +/- 63 ng/mL, P = .82) or lansoprazole administration (C(max): 45.0 +/- 36.6 vs 41.3 +/- 29.4 ng/mL, P = .70; AUC: 128 +/- 87 vs 123 +/- 50, P = .73). Analyses of S18982 pharmacokinetic parameters showed similar results. Coadministration of either omeprazole or lansoprazole did not significantly affect the pharmacokinetics of a single dose of ivabradine. No pharmacodynamic interaction or safety concerns were evidenced.
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pubmed:language |
eng
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pubmed:journal |
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pubmed:citationSubset |
IM
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pubmed:chemical |
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pubmed:status |
MEDLINE
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pubmed:month |
Oct
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pubmed:issn |
0091-2700
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pubmed:author |
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pubmed:issnType |
Print
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pubmed:volume |
46
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
1195-203
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pubmed:meshHeading |
pubmed-meshheading:16988209-2-Pyridinylmethylsulfinylbenzimidazoles,
pubmed-meshheading:16988209-Administration, Oral,
pubmed-meshheading:16988209-Adolescent,
pubmed-meshheading:16988209-Adult,
pubmed-meshheading:16988209-Anti-Ulcer Agents,
pubmed-meshheading:16988209-Area Under Curve,
pubmed-meshheading:16988209-Benzazepines,
pubmed-meshheading:16988209-Capsules,
pubmed-meshheading:16988209-Chromatography, High Pressure Liquid,
pubmed-meshheading:16988209-Cross-Over Studies,
pubmed-meshheading:16988209-Drug Interactions,
pubmed-meshheading:16988209-Electrocardiography,
pubmed-meshheading:16988209-Enzyme Inhibitors,
pubmed-meshheading:16988209-Female,
pubmed-meshheading:16988209-Half-Life,
pubmed-meshheading:16988209-Heart Rate,
pubmed-meshheading:16988209-Humans,
pubmed-meshheading:16988209-Hypotension, Orthostatic,
pubmed-meshheading:16988209-Male,
pubmed-meshheading:16988209-Metabolic Clearance Rate,
pubmed-meshheading:16988209-Omeprazole,
pubmed-meshheading:16988209-Tablets,
pubmed-meshheading:16988209-Time Factors
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pubmed:year |
2006
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pubmed:articleTitle |
Lack of pharmacokinetic interaction between omeprazole or lansoprazole and ivabradine in healthy volunteers: an open-label, randomized, crossover, pharmacokinetic interaction clinical trial.
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pubmed:affiliation |
Clinical Pharmacology Studies Unit, Clinical Pharmacology Service, Hospital Clínico San Carlos, Madrid, Spain. aportoles.hcsc@salud.madrid.org
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pubmed:publicationType |
Journal Article,
Randomized Controlled Trial,
Research Support, Non-U.S. Gov't,
Clinical Trial, Phase I
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