An open-label, parallel, multiple-dose study comparing the pharmacokinetics and gastric acid suppression of rabeprazole extended-release with esomeprazole 40 mg and rabeprazole delayed-release 20 mg in healthy volunteers

Alimentary Pharmacology and Therapeutics

Volumn 33, Issue 7, 2011, Pages 845-854

  Morelli, G ^a   Chen, H ^b   Rossiter, G ^b   Rege, B ^b   Lu, Y ^b  

^a MCGILL UNIVERSITY   (Canada)

^b EISAI INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ESOMEPRAZOLE; RABEPRAZOLE;

ADULT; AREA UNDER THE CURVE; ARTICLE; CONTROLLED STUDY; DELAYED DRUG RELEASE; DRUG BLOOD LEVEL; DRUG ERUPTION; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG MECHANISM; DRUG RELEASE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ELECTROCARDIOGRAM; ENTERIC COATED TABLET; EXTENDED DRUG RELEASE; FEMALE; GASTRIC PH MONITORING; GASTROESOPHAGEAL REFLUX; HUMAN; HUMAN EXPERIMENT; LABORATORY TEST; MALE; MAXIMUM PLASMA CONCENTRATION; MULTIPLE DRUG DOSE; NORMAL HUMAN; PHYSICAL EXAMINATION; PRIORITY JOURNAL; PULSATILE DRUG RELEASE; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; TIME TO MAXIMUM PLASMA CONCENTRATION; VITAL SIGN;

2-PYRIDINYLMETHYLSULFINYLBENZIMIDAZOLES; ADULT; ANTI-ULCER AGENTS; DELAYED-ACTION PREPARATIONS; DRUG THERAPY, COMBINATION; FEMALE; GASTRIC ACID; GASTRIC ACIDITY DETERMINATION; HUMANS; HYDROGEN-ION CONCENTRATION; MALE; MIDDLE AGED; OMEPRAZOLE; STATISTICS AS TOPIC; YOUNG ADULT;

EID: 79952261038     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/j.1365-2036.2011.04580.x     Document Type: Article

References (23)

1. Armstrong D,. Gastroesophageal reflux disease. Curr Opin Pharmacol 2005; 5: 589-95. (Pubitemid 41614457)
2. DeVault KR, Castell DO,. Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease. Am J Gastroenterol 2005; 100: 190-200. (Pubitemid 41623288)
3. Hunt RH,. Importance of pH control in the management of GERD. Arch Intern Med 1999; 159: 649-57. (Pubitemid 29177653)
4. Richter JE, Kahrilas PJ, Johanson J, et al. 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. (Pubitemid 32240711)
5. Kahrilas PJ, Falk GW, Johnson DA, et al. Esomeprazole improves healing and symptom resolution as compared with omeprazole in reflux oesophagitis patients: a randomized controlled trial. The Esomeprazole Study Investigators. Aliment Pharmacol Ther 2000; 14: 1249-58.
6. Castell DO, Kahrilas PJ, Richter JE, et al. Esomeprazole (40 mg) compared with lansoprazole (30 mg) in the treatment of erosive esophagitis. Am J Gastroenterol 2002; 97: 575-83. (Pubitemid 34245883)
7. Labenz J, Armstrong D, Lauritsen K, et al. A randomized comparative study of esomeprazole 40 mg versus pantoprazole 40 mg for healing erosive oesophagitis: the EXPO study. Aliment Pharmacol Ther 2005; 21: 739-46. (Pubitemid 40476079)
8. 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. (Pubitemid 40313949)
9. Nexium (Esomeprazole Magnesium) Delayed Release Capsules Approval Package, NDA Application No.: 21-153 & 21-154. Available at: http://www.accessdata.fda.gov/drugsatfda-docs/nda/2001/21154-Nexium.cfm.
10. Holloway RH, Dent J, Narielvala F,. Relation between oesophageal acid exposure and healing of oesophagitis with omeprazole in patients with severe reflux oesophagitis. Gut 1996; 38: 649-54. (Pubitemid 26167469)
11. Armstrong D,. Review article: gastric pH- the most relevant predictor of benefit in reflux disease. Aliment Pharmacol Ther 2004; 20 (Suppl. 5): 19-26. (Pubitemid 39424904)
12. Katz PO, Ginsberg GG, Hoyle PE, Sostek MB, Monyak JT, Silberg DG,. Relationship between intragastric acid control and healing status in the treatment of moderate to severe erosive esophagitis. Aliment Pharmacol Ther 2007; 25: 617-28.
13. Prescribing Information for Prevacid® (Lansoprazole). Lake Forest, IL: Tap Pharmaceutical Product Inc., 2006.
14. Prescribing Information for Prilosec® (Omeprazole). Wilmington, DE: AstraZeneca LP, 2001.
15. Prescribing Information for Prontonix® (Pantoprazole Sodium). Philadelphia, PA: Wyeth Laboratories, 2004.
16. Prescribing Information for Aciphex® (Rabeprazole). Woodcliff Lake, NJ: Eisai Inc., 2007.
17. Miner P Jr, Katz PO, Chen Y, Sostek M,. Gastric acid control with esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole: a five-way crossover study. Am J Gastroenterol 2003; 98: 2616-20. (Pubitemid 38020098)
18. Gardner JD, Young W, Sloan S, Robinson M, Miner PB Jr,. The effects of changing temperature correction factors on measures of acidity calculated from gastric and esophageal pH recordings. Aliment Pharmacol Ther 2006; 23: 629-38.
19. Miner P, Delemos B, Xiang J, Lococo J, Ieni J,. Effects of a single dose of rabeprazole 20 mg and pantoprazole 40 mg on 24-h intragastric acidity and oesophageal acid exposure: a randomized study in gastro-oesophageal reflux disease patients with a history of nocturnal heartburn. Aliment Pharmacol Ther 2010; 31: 991-1000.
20. Yasuda S, Ohnishi A, Ogawa T, et al. Pharmacokinetic properties of E3810, a new proton pump inhibitor, in healthy male volunteers. Int J Clin Pharmacol Ther 1994; 32: 466-73. (Pubitemid 24277056)
21. Horai Y, Kimura M, Furuie H, et al. Pharmacodynamic effects and kinetic disposition of rabeprazole in relation to CYP2C19 genotypes. Aliment Pharmacol Ther 2001; 15: 793-803. (Pubitemid 32500425)
22. Wilder-Smith CH, Röhss K, Nilsson-Pieschl C, Junghard O, Nyman L,. Esomeprazole 40 mg provides improved intragastric acid control as compared with lansoprazole 30 mg and rabeprazole 20 mg in healthy volunteers. Digestion 2003; 68: 184-8. (Pubitemid 38250507)
23. Warrington S, Baisley K, Boyce M, Tejura B, Morocutti A, Miller N,. Effects of rabeprazole, 20 mg, or esomeprazole, 20 mg, on 24-h intragastric pH and serum gastrin in healthy subjects. Aliment Pharmacol Ther 2002; 16: 1301-7.