Pharmacokinetics of budesonide controlled-release capsules when taken with omeprazole.
OBJECTIVE
To investigate whether omeprazole affects the pharmacokinetics and systemic effects of budesonide controlled-release capsules when the two medications are taken together.


METHODS
Thirteen healthy volunteers were enrolled into a randomized, double-blind, placebo-controlled, cross-over study. Participants received omeprazole, 20 mg/day, or placebo every morning for 5 days, with three 3-mg budesonide controlled-release capsules being given with omeprazole or placebo on day 5. After a 12-day washout period, participants were switched from omeprazole to placebo, or vice versa, and the trial was repeated. Blood samples for pharmacokinetic evaluation and urine samples for cortisol assessments were collected before and after the budesonide doses.


RESULTS
No statistically significant differences were seen between omeprazole and placebo treatment with regard to any of the parameters analysed, including the maximum budesonide plasma concentration, time to concentration maximum, area under the concentration-time curve, mean residence time and urinary excretion of cortisol. Very few adverse events were reported during the trial, and the majority were of mild to moderate severity.


CONCLUSIONS
Omeprazole treatment does not affect the pharmacokinetics or systemic effects of budesonide controlled-release capsules when the two medications are taken simultaneously.
Edsbäcker
S
S
Experimental Medicine, AstraZeneca, Wayne, PA, USA. Staffan.Edsbacker@astrazeneca.com
Larsson
P
P
Bergstrand
M
M
D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D019819:Budesonide / Q000008:administration & dosage / Q000493:pharmacokinetics*; D002214:Capsules; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D009853:Omeprazole / Q000008:administration & dosage / Q000493:pharmacokinetics*
D000893:Anti-Inflammatory Agents; D000897:Anti-Ulcer Agents; D002214:Capsules; D003692:Delayed-Action Preparations; D019819:Budesonide; D009853:Omeprazole