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ID 15022
file
creator
Shimatani, Tomohiko
Inoue, M.
Kuroiwa, T.
Xu, J.
Mieno, H.
Tazuma, S.
subject
Generic product
Intragastric pH
Omeprazole
NDC
Medical sciences
abstract
Background: Generic omeprazole contains the same active ingredient as original omeprazole and require verification of the bioequivalence with original omeprazole. However, very few clinical studies have been reported. Aims: A prospective, randomised, open-label, crossover study to compare acid-suppressive effect of generic omeprazole with that of original omeprazole. Subjects: Seven healthy Helicobacter pylori-negative subjects of CYP2C19 extensive metaboliser. Methods: Intragastric pH was measured for 24 h without medications (placebo) and on day 7 of repeated administration of 10 mg once daily after breakfast of original omeprazole, Omeprazon, or three brands of generic omeprazole, Omeprazole-Towa, Ovulanze or Omerap. Results: Median values of intragastric pH and percentages of time with pH > 4 for 24 h were significantly higher with administration of any omeprazole formulation compared with placebo (P < 0.05, Wilcoxon signed-rank test). Whereas, during the night-time period (20:00-08:00 h), percentages of time with pH > 4 with Omeprazole-Towa and Omerap were not significantly higher than placebo. Compared with Omeprazon, these two parameters for 24 h showed significantly greater inter-subject variations with Omeprazole-Towa (P < 0.05 and P < 0.01, F-test) and Ovulanze (P < 0.05). Conclusions: Acid-suppressive effects of some brands of generic omeprazole are not the same as original omeprazole. These differences might be reflected in clinical outcomes.
journal title
Digestive and Liver Disease
volume
Volume 38
issue
Issue 8
start page
554
end page
559
date of issued
2006-08
publisher
Elsevier
issn
1590-8658
ncid
publisher doi
pubmed id
language
eng
nii type
Journal Article
HU type
Journal Articles
DCMI type
text
format
application/pdf
text version
author
relation is version of URL
http://dx.doi.org/10.1016/j.dld.2006.01.032
department
Graduate School of Biomedical Science