Effect of timing of dosing in relation to food intake on the pharmacokinetics of esomeprazole

British Journal of Clinical Pharmacology

Volumn 64, Issue 3, 2007, Pages 386-390

  Sostek, Mark B ^a   Chen, Yusong ^a   Andersson, Tommy ^a  

^a ASTRAZENECA   (United Kingdom)

Author keywords

Esomeprazole capsules; Food drug interactions; Pharmacokinetics

Indexed keywords

ESOMEPRAZOLE;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CLINICAL TRIAL; COMPARATIVE STUDY; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIET RESTRICTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DOSE REGIMEN; FEMALE; FOOD INTAKE; HUMAN; LIPID DIET; MALE; NORMAL HUMAN; OPEN STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

ADULT; ANTI-ULCER AGENTS; AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; CROSS-OVER STUDIES; DRUG ADMINISTRATION SCHEDULE; EATING; FASTING; FEMALE; FOOD-DRUG INTERACTIONS; HUMANS; MALE; MIDDLE AGED; OMEPRAZOLE;

EID: 34548011225     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2007.02889.x     Document Type: Article

References (12)

1. Richter JE, Kahrilas PJ, Johanson J, Maton P, Breiter JR, Hwang C, Marino V, Hamelin B, Levine JG for the Esomeprazole Study Investigators. Efficacy and safety of esomeprazole compared with omeprazole in GERD patients with erosive esophagitis: a randomized controlled trial. Am J Gastroenterol 2001 96 : 656 65.
2. Fennerty MB, Johanson JF, Hwang C, Sostek M. Efficacy of esomeprazole 40 mg vs. lansoprazole 30 mg for healing moderate to severe erosive oesophagitis. Aliment Pharmacol Ther 2005 21 : 455 63.
3. Andersson T, Röhss K, Bredberg E, Hassan-Alin M. Pharmacokinetics and pharmacodynamics of esomeprazole, the S-isomer of omeprazole. Aliment Pharmacol Ther 2001 15 : 1563 9.
4. Junghard O, Hassan-Alin M, Hasselgren G. The effect of the area under the plasma concentration vs time curve and the maximum plasma concentration of esomeprazole on intragastric pH. Eur J Clin Pharmacol 2002 58 : 453 8.
5. Sostek MB, Chen Y, Skammer W, Winter H, Zhao J, Andersson T. Esomeprazole administered through a nasogastric tube provides bioavailability similar to oral dosing. Aliment Pharmacol Ther 2003 18 : 581 6.
6. World Medical Association Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects. Ferney-Voltaire, France : WMA 1989. Available at http://www.wma.net.
7. European Agency for the Evaluation of Medicinal Products. International Conference on Harmonisation-World Health Organization, Guideline for Good Clinical Practice. ICH Topic E6. Geneva : WHO 2002. Available at http://www.emea.eu.int.
8. Lagerström PO, Persson BA. Determination of omeprazole and metabolites in plasma and urine by liquid chromatography. J Chromatogr 1984 309 : 347 56.
9. Hassan-Alin M, Andersson T, Bredberg E, Röhss K. Pharmacokinetics of esomeprazole after oral and intravenous administration of single and repeated doses to healthy subjects. Eur J Clin Pharmacol 2000 56 : 665 70.
10. Hassan-Alin M, Andersson T, Niazi M, Röhss K. A pharmacokinetic study comparing single and repeated oral doses of 20 mg and 40 mg omeprazole and its two optical isomers, Y-omeprazole (esomeprazole) and R-omeprazole, in healthy subjects. Eur J Clin Pharmacol 2005 60 : 779 84.
11. Benet LZ, Kroetz DL, Sheiner LB. Pharmacokinetics. the dynamics of drug absorption, distribution, and elimination. In : Goodman and Gilman's: the Pharmacological Basis of Therapeutics, 9th edn, eds Hardman JG, Limbird LE, Molinoff PB, Ruddon RW, Gilman AG. New York : McGraw-Hill 1996 : 3 28.
12. Mayer EA. The physiology of gastric storage and emptying. In : Physiology of the Gastrointestinal Tract, 3rd edn, eds Johnson LR, Alpers DH, Jacobson ED, Christensen J, Walsh JH. New York : Raven Press 1994 : 929 76.