Trial reportClinical drug investigation2011
Effect of fluoxetine on the pharmacokinetics of lansoprazole: a two-treatment period study in healthy male subjects.
Trial report in Clinical drug investigation, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
3 citing papers in PubMed, 9 citations in OpenAlex.
- Application of nanoparticles for oral delivery of acid-labile lansoprazole in the treatment of gastric ulcer: in vitro and in vivo evaluations.International journal of nanomedicine · 2015Article
- Fluoxetine- and norfluoxetine-mediated complex drug-drug interactions: in vitro to in vivo correlation of effects on CYP2D6, CYP2C19, and CYP3A4.Clinical pharmacology and therapeutics · 2014Article
- Stereoselective inhibition of CYP2C19 and CYP3A4 by fluoxetine and its metabolite: implications for risk assessment of multiple time-dependent inhibitor systems.Drug metabolism and disposition: the biological fate of chemicals · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundFluoxetine is an inhibitor of the main metabolizing enzymes of lansoprazole and could influence the pharmacokinetics of lansoprazole. The changes in lansoprazole pharmacokinetics could have clinical significance concerning the safety of the therapy.
objectiveThe aim of this study was to evaluate the pharmacokinetic interaction between fluoxetine and lansoprazole in healthy subjects.
methodsA dose of lansoprazole 30 mg, alone or in combination with fluoxetine 60 mg, was administered to 18 healthy male subjects in a two-treatment study design, separated by an 8-day period in which fluoxetine alone was administered as a single oral daily dose. Plasma concentrations of lansoprazole were determined during a 12-hour period following drug administration. Lansoprazole plasma concentrations were determined by a validated liquid chromatography-mass spectrometry method. The pharmacokinetic parameters of lansoprazole were calculated using non-compartmental analysis.
resultsIn the two periods of treatment, the mean maximum plasma concentration (C(max)) values were 817 ng/mL (lansoprazole alone) and 1370 ng/mL (lansoprazole in combination with fluoxetine after pre-treatment with fluoxetine for 8 days) [p < 0.0001]. The observed area under the plasma concentration-time curve (AUC) from time zero to time of last measurable concentration values were 2400 and 6220 ng · h/mL (p < 0.0001), respectively, and the AUC from time zero to infinity values were 2480 and 7290 ng · h/mL (p < 0.0001), respectively. The time to reach C(max) values were 2.72 and 2.64 hours, respectively. The elimination rate constant from the central compartment values were 0.50 and 0.21 h-1, respectively (p < 0.0001). The elimination half-life values were 1.47 and 3.56 hours (p < 0.0001), respectively, and the mean residence times were 4.0 and 6.9 hours (p < 0.0001), respectively.
conclusionThe data demonstrate a pharmacokinetic interaction between fluoxetine and lansoprazole and suggest that the observed interaction may be clinically significant, although its clinical relevance has yet to be confirmed.
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