Administration of an alginate based gastric reflux suppressant on the bioavailability of omeprazole.

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dc.contributor.authorDettmar, P Wen_US
dc.contributor.authorHampson, F Cen_US
dc.contributor.authorJain, Aen_US
dc.contributor.authorChoubey, Sen_US
dc.contributor.authorLittle, S Len_US
dc.contributor.authorBaxter, Ten_US
dc.date.accessioned2006-04-20en_US
dc.date.accessioned2009-05-27T07:31:47Z
dc.date.available2006-04-20en_US
dc.date.available2009-05-27T07:31:47Z
dc.date.issued2006-04-20en_US
dc.description.abstractBACKGROUND & 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.en_US
dc.description.affiliationReckitt Benckiser Healthcare (UK) Ltd., Dansom Lane, Hull HU8 7DS, UK. peter.dettmar@technostics.comen_US
dc.identifier.citationDettmar 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): 517-24en_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/21070
dc.language.isoengen_US
dc.source.urihttps://icmr.nic.in/ijmr/ijmr.htmen_US
dc.subject.meshAdolescenten_US
dc.subject.meshAdulten_US
dc.subject.meshAlginates --administration & dosageen_US
dc.subject.meshAntacids --administration & dosageen_US
dc.subject.meshBiological Availabilityen_US
dc.subject.meshCross-Over Studiesen_US
dc.subject.meshDrug Interactionsen_US
dc.subject.meshDrug Therapy, Combinationen_US
dc.subject.meshGastroesophageal Reflux --drug therapyen_US
dc.subject.meshHumansen_US
dc.subject.meshMaleen_US
dc.subject.meshOmeprazole --administration & dosageen_US
dc.subject.meshProton Pumps --antagonists & inhibitorsen_US
dc.titleAdministration of an alginate based gastric reflux suppressant on the bioavailability of omeprazole.en_US
dc.typeJournal Articleen_US
dc.typeRandomized Controlled Trialen_US
dc.typeResearch Support, Non-U.S. Gov'ten_US
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