Key result
Co-administration of esomeprazole (40 mg) and ASA (325 mg) showed no pharmacokinetic interaction, with a geometric mean ratio for ASA AUCtau of 1.04 (90% CI 1.00-1.09).
Why the study?
Does co-administration of esomeprazole and acetylsalicylic acid alter their pharmacokinetics in healthy volunteers?
RCT (n=55)
Open-label
3-way crossover
Does co-administration of esomeprazole and acetylsalicylic acid alter their pharmacokinetics in healthy volunteers?
Effect estimate: Geometric mean ratio 1.04 for AUCtau (95% CI 1.00 - 1.09)
Co-administration of esomeprazole 40 mg and acetylsalicylic acid 325 mg does not result in a clinically significant pharmacokinetic interaction.
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.
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Niazi et al. (2009) conducted an RCT in Healthy volunteers (n=55). Esomeprazole and acetylsalicylic acid (ASA) vs. Esomeprazole alone or ASA alone was evaluated on Steady-state area under the concentration-time curve (AUCtau) and observed maximum plasma concentration (Cmax) of ASA +/- esomeprazole (Geometric mean ratio 1.04 for AUCtau, 95% CI 1.00 - 1.09). Co-administration of esomeprazole (40 mg) and ASA (325 mg) showed no pharmacokinetic interaction, with a geometric mean ratio for ASA AUCtau of 1.04 (90% CI 1.00-1.09).
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