Acid-suppressive effects of generic omeprazole: Comparison of three brands of generic omeprazole with original omeprazole
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. A prospective, randomised, open-label, crossover study to compare acid-suppressive effect of g...
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| Veröffentlicht in: | Digestive and liver disease 2006-08, Vol.38 (8), p.554-559 |
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| creator | Shimatani, T. Inoue, M. Kuroiwa, T. Xu, J. Mieno, H. Tazuma, S. |
| description | 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.
A prospective, randomised, open-label, crossover study to compare acid-suppressive effect of generic omeprazole with that of original omeprazole.
Seven healthy
Helicobacter pylori-negative subjects of CYP2C19 extensive metaboliser.
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.
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).
Acid-suppressive effects of some brands of generic omeprazole are not the same as original omeprazole. These differences might be reflected in clinical outcomes. |
| doi_str_mv | 10.1016/j.dld.2006.01.032 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_68651168</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S1590865806000466</els_id><sourcerecordid>68651168</sourcerecordid><originalsourceid>FETCH-LOGICAL-c394t-f21e709ae7d52157a02f93591f3735dbab53246d5f957717ec4c2c0d5f9464d33</originalsourceid><addsrcrecordid>eNp9kMtKxDAUhoMo3h_AjXTlrjWXJml1JYM3ENzoOmSSE83QNjXpKPr0ZpgB3ejqnEO-_4d8CJ0QXBFMxPmisp2tKMaiwqTCjG6hfdLIpmRc0O288xaXjeDNHjpIaYExJYLjXbSXB61l0-6jzyvjbZmW4xghJf8OBTgHZkpFcMULDBC9KUIPY9RfoYOLYhb6UUefwrAiptcIUMyjHuwfieLDT69FiP7FD7r79XCEdpzuEhxv5iF6vrl-mt2VD4-397Orh9Kwtp5KRwlI3GqQllPCpcbUtYy3xDHJuJ3rOWe0Fpa7lktJJJjaUINXdy1qy9ghOlv3jjG8LSFNqvfJQNfpAcIyKZEFESKaDJI1aGJIKYJTY_S9jp-KYLXyrRYq-1Yr3woTlX3nzOmmfDnvwf4kNoIzcLkGIH_x3UNUyXgYDFgfs2Zlg_-n_htFzZKT</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>68651168</pqid></control><display><type>article</type><title>Acid-suppressive effects of generic omeprazole: Comparison of three brands of generic omeprazole with original omeprazole</title><source>MEDLINE</source><source>ScienceDirect Journals (5 years ago - present)</source><creator>Shimatani, T. ; Inoue, M. ; Kuroiwa, T. ; Xu, J. ; Mieno, H. ; Tazuma, S.</creator><creatorcontrib>Shimatani, T. ; Inoue, M. ; Kuroiwa, T. ; Xu, J. ; Mieno, H. ; Tazuma, S.</creatorcontrib><description>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.
A prospective, randomised, open-label, crossover study to compare acid-suppressive effect of generic omeprazole with that of original omeprazole.
Seven healthy
Helicobacter pylori-negative subjects of CYP2C19 extensive metaboliser.
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.
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).
Acid-suppressive effects of some brands of generic omeprazole are not the same as original omeprazole. These differences might be reflected in clinical outcomes.</description><identifier>ISSN: 1590-8658</identifier><identifier>EISSN: 1878-3562</identifier><identifier>DOI: 10.1016/j.dld.2006.01.032</identifier><identifier>PMID: 16524789</identifier><language>eng</language><publisher>Netherlands: Elsevier Ltd</publisher><subject>Adult ; Anti-Ulcer Agents - administration & dosage ; Anti-Ulcer Agents - pharmacokinetics ; Aryl Hydrocarbon Hydroxylases - drug effects ; Chemistry, Pharmaceutical ; Cross-Over Studies ; Cytochrome P-450 CYP2C19 ; Drugs, Generic ; Enzyme Inhibitors - administration & dosage ; Enzyme Inhibitors - pharmacokinetics ; Female ; Gastric Acid - secretion ; Gastric Acidity Determination ; Gastric Mucosa - drug effects ; Gastric Mucosa - secretion ; Generic product ; Genotype ; Helicobacter pylori ; Humans ; Hydrogen-Ion Concentration - drug effects ; Intragastric pH ; Japan ; Male ; Mixed Function Oxygenases - drug effects ; Omeprazole ; Omeprazole - administration & dosage ; Omeprazole - pharmacokinetics ; Prospective Studies ; Reference Values ; Therapeutic Equivalency</subject><ispartof>Digestive and liver disease, 2006-08, Vol.38 (8), p.554-559</ispartof><rights>2006 Editrice Gastroenterologica Italiana S.r.l.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c394t-f21e709ae7d52157a02f93591f3735dbab53246d5f957717ec4c2c0d5f9464d33</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.dld.2006.01.032$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3548,27923,27924,45994</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16524789$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Shimatani, T.</creatorcontrib><creatorcontrib>Inoue, M.</creatorcontrib><creatorcontrib>Kuroiwa, T.</creatorcontrib><creatorcontrib>Xu, J.</creatorcontrib><creatorcontrib>Mieno, H.</creatorcontrib><creatorcontrib>Tazuma, S.</creatorcontrib><title>Acid-suppressive effects of generic omeprazole: Comparison of three brands of generic omeprazole with original omeprazole</title><title>Digestive and liver disease</title><addtitle>Dig Liver Dis</addtitle><description>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.
A prospective, randomised, open-label, crossover study to compare acid-suppressive effect of generic omeprazole with that of original omeprazole.
Seven healthy
Helicobacter pylori-negative subjects of CYP2C19 extensive metaboliser.
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.
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).
Acid-suppressive effects of some brands of generic omeprazole are not the same as original omeprazole. These differences might be reflected in clinical outcomes.</description><subject>Adult</subject><subject>Anti-Ulcer Agents - administration & dosage</subject><subject>Anti-Ulcer Agents - pharmacokinetics</subject><subject>Aryl Hydrocarbon Hydroxylases - drug effects</subject><subject>Chemistry, Pharmaceutical</subject><subject>Cross-Over Studies</subject><subject>Cytochrome P-450 CYP2C19</subject><subject>Drugs, Generic</subject><subject>Enzyme Inhibitors - administration & dosage</subject><subject>Enzyme Inhibitors - pharmacokinetics</subject><subject>Female</subject><subject>Gastric Acid - secretion</subject><subject>Gastric Acidity Determination</subject><subject>Gastric Mucosa - drug effects</subject><subject>Gastric Mucosa - secretion</subject><subject>Generic product</subject><subject>Genotype</subject><subject>Helicobacter pylori</subject><subject>Humans</subject><subject>Hydrogen-Ion Concentration - drug effects</subject><subject>Intragastric pH</subject><subject>Japan</subject><subject>Male</subject><subject>Mixed Function Oxygenases - drug effects</subject><subject>Omeprazole</subject><subject>Omeprazole - administration & dosage</subject><subject>Omeprazole - pharmacokinetics</subject><subject>Prospective Studies</subject><subject>Reference Values</subject><subject>Therapeutic Equivalency</subject><issn>1590-8658</issn><issn>1878-3562</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2006</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kMtKxDAUhoMo3h_AjXTlrjWXJml1JYM3ENzoOmSSE83QNjXpKPr0ZpgB3ejqnEO-_4d8CJ0QXBFMxPmisp2tKMaiwqTCjG6hfdLIpmRc0O288xaXjeDNHjpIaYExJYLjXbSXB61l0-6jzyvjbZmW4xghJf8OBTgHZkpFcMULDBC9KUIPY9RfoYOLYhb6UUefwrAiptcIUMyjHuwfieLDT69FiP7FD7r79XCEdpzuEhxv5iF6vrl-mt2VD4-397Orh9Kwtp5KRwlI3GqQllPCpcbUtYy3xDHJuJ3rOWe0Fpa7lktJJJjaUINXdy1qy9ghOlv3jjG8LSFNqvfJQNfpAcIyKZEFESKaDJI1aGJIKYJTY_S9jp-KYLXyrRYq-1Yr3woTlX3nzOmmfDnvwf4kNoIzcLkGIH_x3UNUyXgYDFgfs2Zlg_-n_htFzZKT</recordid><startdate>20060801</startdate><enddate>20060801</enddate><creator>Shimatani, T.</creator><creator>Inoue, M.</creator><creator>Kuroiwa, T.</creator><creator>Xu, J.</creator><creator>Mieno, H.</creator><creator>Tazuma, S.</creator><general>Elsevier Ltd</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20060801</creationdate><title>Acid-suppressive effects of generic omeprazole: Comparison of three brands of generic omeprazole with original omeprazole</title><author>Shimatani, T. ; Inoue, M. ; Kuroiwa, T. ; Xu, J. ; Mieno, H. ; Tazuma, S.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c394t-f21e709ae7d52157a02f93591f3735dbab53246d5f957717ec4c2c0d5f9464d33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2006</creationdate><topic>Adult</topic><topic>Anti-Ulcer Agents - administration & dosage</topic><topic>Anti-Ulcer Agents - pharmacokinetics</topic><topic>Aryl Hydrocarbon Hydroxylases - drug effects</topic><topic>Chemistry, Pharmaceutical</topic><topic>Cross-Over Studies</topic><topic>Cytochrome P-450 CYP2C19</topic><topic>Drugs, Generic</topic><topic>Enzyme Inhibitors - administration & dosage</topic><topic>Enzyme Inhibitors - pharmacokinetics</topic><topic>Female</topic><topic>Gastric Acid - secretion</topic><topic>Gastric Acidity Determination</topic><topic>Gastric Mucosa - drug effects</topic><topic>Gastric Mucosa - secretion</topic><topic>Generic product</topic><topic>Genotype</topic><topic>Helicobacter pylori</topic><topic>Humans</topic><topic>Hydrogen-Ion Concentration - drug effects</topic><topic>Intragastric pH</topic><topic>Japan</topic><topic>Male</topic><topic>Mixed Function Oxygenases - drug effects</topic><topic>Omeprazole</topic><topic>Omeprazole - administration & dosage</topic><topic>Omeprazole - pharmacokinetics</topic><topic>Prospective Studies</topic><topic>Reference Values</topic><topic>Therapeutic Equivalency</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Shimatani, T.</creatorcontrib><creatorcontrib>Inoue, M.</creatorcontrib><creatorcontrib>Kuroiwa, T.</creatorcontrib><creatorcontrib>Xu, J.</creatorcontrib><creatorcontrib>Mieno, H.</creatorcontrib><creatorcontrib>Tazuma, S.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Digestive and liver disease</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Shimatani, T.</au><au>Inoue, M.</au><au>Kuroiwa, T.</au><au>Xu, J.</au><au>Mieno, H.</au><au>Tazuma, S.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Acid-suppressive effects of generic omeprazole: Comparison of three brands of generic omeprazole with original omeprazole</atitle><jtitle>Digestive and liver disease</jtitle><addtitle>Dig Liver Dis</addtitle><date>2006-08-01</date><risdate>2006</risdate><volume>38</volume><issue>8</issue><spage>554</spage><epage>559</epage><pages>554-559</pages><issn>1590-8658</issn><eissn>1878-3562</eissn><abstract>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.
A prospective, randomised, open-label, crossover study to compare acid-suppressive effect of generic omeprazole with that of original omeprazole.
Seven healthy
Helicobacter pylori-negative subjects of CYP2C19 extensive metaboliser.
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.
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).
Acid-suppressive effects of some brands of generic omeprazole are not the same as original omeprazole. These differences might be reflected in clinical outcomes.</abstract><cop>Netherlands</cop><pub>Elsevier Ltd</pub><pmid>16524789</pmid><doi>10.1016/j.dld.2006.01.032</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1590-8658 |
| ispartof | Digestive and liver disease, 2006-08, Vol.38 (8), p.554-559 |
| issn | 1590-8658 1878-3562 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_68651168 |
| source | MEDLINE; ScienceDirect Journals (5 years ago - present) |
| subjects | Adult Anti-Ulcer Agents - administration & dosage Anti-Ulcer Agents - pharmacokinetics Aryl Hydrocarbon Hydroxylases - drug effects Chemistry, Pharmaceutical Cross-Over Studies Cytochrome P-450 CYP2C19 Drugs, Generic Enzyme Inhibitors - administration & dosage Enzyme Inhibitors - pharmacokinetics Female Gastric Acid - secretion Gastric Acidity Determination Gastric Mucosa - drug effects Gastric Mucosa - secretion Generic product Genotype Helicobacter pylori Humans Hydrogen-Ion Concentration - drug effects Intragastric pH Japan Male Mixed Function Oxygenases - drug effects Omeprazole Omeprazole - administration & dosage Omeprazole - pharmacokinetics Prospective Studies Reference Values Therapeutic Equivalency |
| title | Acid-suppressive effects of generic omeprazole: Comparison of three brands of generic omeprazole with original omeprazole |
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