Gastric reacidification with betaine HCl in healthy volunteers with rabeprazole-induced hypochlorhydria

Molecular Pharmaceutics

Volumn 10, Issue 11, 2013, Pages 4032-4037

  Yago, Marc R ^a   Frymoyer, Adam R ^b   Smelick, Gillian S ^c   Frassetto, Lynda A ^d   Budha, Nageshwar R ^c   Dresser, Mark J ^c   Ware, Joseph A ^c   Benet, Leslie Z ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b STANFORD UNIVERSITY   (United States)

^c GENENTECH INC   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

betaine hydrochloride; drug drug interaction (DDI); gastric reacidification; hypochlorhydria; pH dependent solubility; proton pump inhibitor (PPI)

Indexed keywords

BETAINE; RABEPRAZOLE;

ACHLORHYDRIA; ACIDIFICATION; ADULT; AREA UNDER THE CURVE; ARTICLE; DRUG POTENCY; FEMALE; GASTRIC PH MONITORING; GASTRIC REACIDIFICATION; GASTROINTESTINAL SYMPTOM; HUMAN; HUMAN EXPERIMENT; MALE; NORMAL HUMAN; PILOT STUDY; PRIORITY JOURNAL; STOMACH PH; UNSPECIFIED SIDE EFFECT;

ACHLORHYDRIA; ADULT; ANTI-ULCER AGENTS; BETAINE; FEMALE; HEALTHY VOLUNTEERS; HUMANS; HYDROGEN-ION CONCENTRATION; MALE; MIDDLE AGED; PROTON PUMP INHIBITORS; RABEPRAZOLE;

EID: 84887355869     PISSN: 15438384     EISSN: 15438392     Source Type: Journal    
DOI: 10.1021/mp4003738     Document Type: Article

References (21)

1. Chin, T. W.; Loeb, M.; Fong, I. W. Effects of an Acidic Beverage (Coca-Cola) on Absorption of Ketoconazole Antimicrob. Agents Chemother. 1995, 39, 1671-1675
2. Yin, O. Q.; Gallagher, N.; Fischer, D.; Demirhan, E.; Zhou, W.; Golor, G.; Schran, H. Effect of the Proton Pump Inhibitor Esomeprazole on the Oral Absorption and Pharmacokinetics of Nilotinib J. Clin. Pharmacol. 2010, 50, 960-967
3. Eley, T.; Luo, F. R.; Agrawal, S.; Sanil, A.; Manning, J.; Li, T.; Blackwood-Chirchir, A.; Bertz, R. Phase I Study of the Effect of Gastric Acid Ph Modulators on the Bioavailability of Oral Dasatinib in Healthy Subjects J. Clin. Pharmacol. 2009, 49, 700-709
4. Kis, O.; Zastre, J. A.; Ramaswamy, M.; Bendayan, R. pH Dependence of Organic Anion-Transporting Polypeptide 2b1 in Caco-2 Cells: Potential Role in Antiretroviral Drug Oral Bioavailability and Drug-Drug Interactions J. Pharmacol. Exp. Ther. 2010, 334, 1009-1022
5. Zhu, L.; Persson, A.; Mahnke, L.; Eley, T.; Li, T.; Xu, X.; Agarwala, S.; Dragone, J.; Bertz, R. Effect of Low-Dose Omeprazole (20 mg Daily) on the Pharmacokinetics of Multiple-Dose Atazanavir with Ritonavir in Healthy Subjects J. Clin. Pharmacol. 2011, 51, 368-377
6. Itraconazole (Package Insert). Eon Labs, Inc.: Laurelton, NY, 2012.
7. Jaruratanasirikul, S.; Sriwiriyajan, S. Effect of Omeprazole on the Pharmacokinetics of Itraconazole Eur. J. Clin. Pharmacol. 1998, 54, 159-161
8. Blum, R. A.; D'Andrea, D. T.; Florentino, B. M.; Wilton, J. H.; Hilligoss, D. M.; Gardner, M. J.; Henry, E. B.; Goldstein, H.; Schentag, J. J. Increased Gastric pH and the Bioavailability of Fluconazole and Ketoconazole Ann. Intern. Med. 1991, 114, 755-757
9. Agarwala, S. G., K.; Eley, T.; Wang, Y.; Hughes, E.; Grasela, D., Pharmacokinetic Interaction between Atazanavir and Omeprazole in Healthy Subjects. Presented at the 3rd IAS Conference on HIV Pathogenesis and Treatment, Rio de Janiero, Brazil, July 24-27, 2005; Poster #163.
10. Knapp, M. J.; Berardi, R. R.; Dressman, J. B.; Rider, J. M.; Carver, P. L. Modification of Gastric pH with Oral Glutamic Acid Hydrochloride Clin Pharm. 1991, 10, 866-869
11. Designs for Health. Quality and Manufacturing-NSF Certification. http://www.designsforhealth.com/QualityManufacturing-QualityandEfficacy- NSFCertification.html (accessed August 19, 2013).
12. Peghini, P. L.; Katz, P. O.; Bracy, N. A.; Castell, D. O. Nocturnal Recovery of Gastric Acid Secretion with Twice-Daily Dosing of Proton Pump Inhibitors Am. J. Gastroenterol. 1998, 93, 763-767
13. El-Omar, E. M.; Oien, K.; El-Nujumi, A.; Gillen, D.; Wirz, A.; Dahill, S.; Williams, C.; Ardill, J. E.; McColl, K. E. Helicobacter Pylori Infection and Chronic Gastric Acid Hyposecretion Gastroenterology 1997, 113, 15-24
14. Cohen, S. Gastritis and Peptic Ulcer Disease. In The Merck Manual for Health Care Professionals, 19 th ed. [Online]; Albert, R. K., Eds.; Gastrointestinal Disorders; Cohen, S., Ed.; Merck Sharp & Dohme Corp.: Whitehouse Station, NJ, 2012. http://www.merckmanuals.com/professional/ gastrointestinal-disorders/gastritis-and-peptic-ulcer-disease/ overview-of-acid-secretion.html (accessed May 1, 2013).
15. Fischer, L. M.; Scearce, J. A.; Mar, M. H.; Patel, J. R.; Blanchard, R. T.; Macintosh, B. A.; Busby, M. G.; Zeisel, S. H. Ad Libitum Choline Intake in Healthy Individuals Meets or Exceeds the Proposed Adequate Intake Level J. Nutr. 2005, 135, 826-829
16. Betaine Anhydrous for Oral Solution (Cystadane®, Package Insert). Rare Disease Therapeutics, Inc.: Franklin, TN.
17. The US Food and Drug Administration. Guidance for Industry-Waiver of In Vitro Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmacetics Classification System. 2000.
18. Hoogerwerf, W. A.; Pasricha, P. J. Pharmacotherapy of Gastric Acidity, Peptic Ulcers, and Gastroesophageal Reflux Disease. In Goodman & Gilman's The Pharmacological Basis of Therapeutics, 11 th ed.; Brunton, L. L.; Lazo, J. S.; Parker, K. L., Eds.; McGraw-Hill: New York, 2006; pp 967-981.
19. Walsh, J. H.; Richardson, C. T.; Fordtran, J. S. pH Dependence of Acid Secretion and Gastrin Release in Normal and Ulcer Subjects J. Clin. Invest. 1975, 55, 462-468
20. Budha, N. R.; Frymoyer, A.; Smelick, G. S.; Jin, J. Y.; Yago, M. R.; Dresser, M. J.; Holden, S. N.; Benet, L. Z.; Ware, J. A. Drug Absorption Interactions between Oral Targeted Anticancer Agents and PPIs: Is pH-Dependent Solubility the Achilles Heel of Targeted Therapy? Clin. Pharmacol. Ther. 2012, 92, 203-213
21. Smelick, G. S.; Heffron, T.; Chu, L.; West, D. A.; DuVall, S. L.; Lum, B.; Budha, N. R.; Holden, S. N.; Benet, L. Z.; Frymoyer, A. R.; Dresser, M. J.; Ware, J. A. Prevalence of Acid-Reducing Agents (ARA) in Cancer Populations: ARA Drug-Drug Interaction Potential for Molecularly Targeted Agents in Clinical Development. Mol. Pharmaceutics, submitted.