title: Evaluation of the pharmacokinetic interaction between esomeprazole (40 mg) and acetylsalicylic acid (325 mg) in healthy volunteers.
abstract: OBJECTIVE
  To evaluate the effect of esomeprazole on the pharmacokinetics of low-dose acetylsalicylic acid (ASA) during repeated co-administration.
  
  
  METHODS
  This was an open, randomized, 3-way crossover study in 55 healthy volunteers. Treatment periods comprised 5 days' oral esomeprazole (40 mg) or ASA (325 mg) alone, or in combination, separated by washout of >or= 13 days. The primary pharmacokinetic end points were steady-state area under the concentration-time curve (AUCtau) and observed maximum plasma concentration (Cmax) of ASA +/- esomeprazole.
  
  
  RESULTS
  The estimates (90% confidence interval) of the geometric mean ratios for AUCtau and Cmax of ASA +/- esomeprazole were 1.04 (1.00 - 1.09) and 1.12 (1.03 - 1.22), respectively. Corresponding results for esomeprazole +/- ASA were 0.93 (0.89 - 0.98) and 0.96 (0.91 - 1.01), respectively. Administration of esomeprazole and ASA in combination was well tolerated.
  
  
  CONCLUSIONS
  There was no pharmacokinetic interaction between esomeprazole (40 mg) and ASA (325 mg) during repeated co-administration in healthy volunteers.
authors.affiliation: AstraZeneca R&D, Mölndal, Sweden. Mohammad.Niazi@astrazeneca.com
authors.forename: M
authors.initials: M
authors.lastname: Niazi
authors.forename: T
authors.initials: T
authors.lastname: Andersson
authors.forename: E
authors.initials: E
authors.lastname: Nauclér
authors.forename: M
authors.initials: M
authors.lastname: Sundin
authors.forename: J
authors.initials: J
authors.lastname: Naesdal
mesh_terms: D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000493:pharmacokinetics* / Q000494:pharmacology*; D000897:Anti-Ulcer Agents / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000494:pharmacology*; D019540:Area Under Curve; D001241:Aspirin / Q000493:pharmacokinetics* / Q000494:pharmacology*; D018592:Cross-Over Studies; D004347:Drug Interactions; D064098:Esomeprazole / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000494:pharmacology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D000897:Anti-Ulcer Agents; D064098:Esomeprazole; D001241:Aspirin