Administration of an alginate based gastric reflux suppressant on the bioavailability of omeprazole.
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2006-04-20
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Abstract
BACKGROUND & OBJECTIVE: Omeprazole treats gastro-oesophageal reflux disease (GORD) by inhibition of acid secretion whereas alginate based reflux suppressants work by forming a low density raft of near neutral pH which floats on the stomach contents and physically impedes gastro-oesophageal reflux. There is limited pharmacokinetic information regarding possible drug interaction between these two types of products, although these may be frequently co-prescribed to improve symptom control in GORD patients. This study was designed to determine whether the administration of a 10 per cent w/v liquid alginate suspension affected the pharmacokinetic profile of omeprazole.
METHODS: This was a randomized, two-treatment, two-sequence, two-period crossover study in 26 volunteers. Each treatment was dosed for 3 consecutive days with a washout period of 7 days between dosing periods. Blood samples for pharmacokinetic analysis were taken over the 24 h period following the final dose of omeprazole.
RESULTS: Geometric means and ratios were as follows: C(max) was 555 for omeprazole/alginate and 558 for omeprazole alone (ratio 99.55%, 90% confidence interval 82.75-119.75%; AUC(0-t) was 2050 for omeprazole/alginate and 2094 for omeprazole alone (ratio 97.90%, 90% confidence interval 87.83-109.12%); AUC(0-a) was 2247 for omeprazole/alginate and 2231 for omeprazole alone (ratio 100.74%, 90% confidence interval 90.05-112.70%). Mean values for T(max), K(el) and T(1/2) were also similar for the two treatment regimens. INTERPRETATION & CONCLUSION: As the 90 per cent confidence intervals for the geometric mean ratios for C(max), AUC(0-t), and AUC(0-alpha) are all contained within the bioequivalence interval of 80-125 per cent, it can be concluded that the administration of this liquid alginate suspension does not affect the pharmacokinetic profile of omeprazole.
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Dettmar PW, Hampson FC, Jain A, Choubey S, Little SL, Baxter T. Administration of an alginate based gastric reflux suppressant on the bioavailability of omeprazole. Indian Journal of Medical Research. 2006 Apr; 123(4): 517-24