| Item type |
デフォルトアイテムタイプ_（フル）(1) |
| 公開日 |
2023-03-18 |
| タイトル |
|
|
タイトル |
Acid-suppressive effects of generic omeprazole: Comparison of three brands of generic omeprazole with original omeprazole |
|
言語 |
en |
| 作成者 |
Shimatani, Tomohiko
Inoue, M.
Kuroiwa, T.
Xu, J.
Mieno, H.
Tazuma, S.
|
| アクセス権 |
|
|
アクセス権 |
open access |
|
アクセス権URI |
http://purl.org/coar/access_right/c_abf2 |
| 主題 |
|
|
主題Scheme |
Other |
|
主題 |
Generic product |
| 主題 |
|
|
主題Scheme |
Other |
|
主題 |
Intragastric pH |
| 主題 |
|
|
主題Scheme |
Other |
|
主題 |
Omeprazole |
| 主題 |
|
|
主題Scheme |
NDC |
|
主題 |
490 |
| 内容記述 |
|
|
内容記述 |
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. |
|
言語 |
en |
| 出版者 |
|
|
出版者 |
Elsevier |
| 言語 |
|
|
言語 |
eng |
| 資源タイプ |
|
|
資源タイプ識別子 |
http://purl.org/coar/resource_type/c_6501 |
|
資源タイプ |
journal article |
| 出版タイプ |
|
|
出版タイプ |
AO |
|
出版タイプResource |
http://purl.org/coar/version/c_b1a7d7d4d402bcce |
| 関連情報 |
|
|
|
識別子タイプ |
DOI |
|
|
関連識別子 |
10.1016/j.dld.2006.01.032 |
| 関連情報 |
|
|
|
識別子タイプ |
PMID |
|
|
関連識別子 |
16524789 |
| 関連情報 |
|
|
関連タイプ |
isVersionOf |
|
|
識別子タイプ |
DOI |
|
|
関連識別子 |
http://dx.doi.org/10.1016/j.dld.2006.01.032 |
| 収録物識別子 |
|
|
収録物識別子タイプ |
ISSN |
|
収録物識別子 |
1590-8658 |
| 収録物識別子 |
|
|
収録物識別子タイプ |
NCID |
|
収録物識別子 |
AA11610665 |
| 開始ページ |
|
|
開始ページ |
554 |
| 書誌情報 |
Digestive and Liver Disease
Digestive and Liver Disease
巻 38,
号 8,
p. 554-559,
発行日 2006-08
|
| 旧ID |
15022 |
DLD_38_554.pdf (290.6 KB)
