Comparable bioavailability of two esophago-gastric protective formulations containing pamidronate. A cross-over trial in healthy young adults
The net absorbable amount of pamidronate (APD), according to AUC values assessed in blood, in the customary dose interval of 24 hours, was found to be similar in 8 healthy young volunteers, who received single doses of 3 capsules of 100 mg APD (AUC0-24 = 510.3 +/- 91.5 micrograms/L x h-1) and 2 tabl...
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| Veröffentlicht in: | Medicina (Buenos Aires) 2002, Vol.62 (4), p.317-322 |
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| container_title | Medicina (Buenos Aires) |
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| creator | Roldán, Emilio J A Quattrocchi, Oscar Zanchetta, Jose Plotkin, Horacio Araujo, Graciela Piccinni, Enrique |
| description | The net absorbable amount of pamidronate (APD), according to AUC values assessed in blood, in the customary dose interval of 24 hours, was found to be similar in 8 healthy young volunteers, who received single doses of 3 capsules of 100 mg APD (AUC0-24 = 510.3 +/- 91.5 micrograms/L x h-1) and 2 tablets of 150 mg (AUC0-24 = 580.5 +/- 117.6 micrograms/L x h-1; p = 0.58) in the fasting state. Both formulations present acid-resistant coatings, designed to protect the mucosa of the upper digestive system from contact with insoluble particles of the bisphosphonates. Tmax values were different, and Cmax values presented a wide inter-individual variation, so that both formulations were not strictly bioequivalent. However, these latter factors were of minor clinical importance given the kinetic features of the bisphosphonates. In conclusion, both formulations afforded comparable bioavailability; that is to say that they can provide a sufficient amount of APD within the studied dose interval, so as to cause similar clinical effects. |
| format | Article |
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A cross-over trial in healthy young adults</title><source>MEDLINE</source><source>EZB-FREE-00999 freely available EZB journals</source><creator>Roldán, Emilio J A ; Quattrocchi, Oscar ; Zanchetta, Jose ; Plotkin, Horacio ; Araujo, Graciela ; Piccinni, Enrique</creator><creatorcontrib>Roldán, Emilio J A ; Quattrocchi, Oscar ; Zanchetta, Jose ; Plotkin, Horacio ; Araujo, Graciela ; Piccinni, Enrique</creatorcontrib><description>The net absorbable amount of pamidronate (APD), according to AUC values assessed in blood, in the customary dose interval of 24 hours, was found to be similar in 8 healthy young volunteers, who received single doses of 3 capsules of 100 mg APD (AUC0-24 = 510.3 +/- 91.5 micrograms/L x h-1) and 2 tablets of 150 mg (AUC0-24 = 580.5 +/- 117.6 micrograms/L x h-1; p = 0.58) in the fasting state. Both formulations present acid-resistant coatings, designed to protect the mucosa of the upper digestive system from contact with insoluble particles of the bisphosphonates. Tmax values were different, and Cmax values presented a wide inter-individual variation, so that both formulations were not strictly bioequivalent. However, these latter factors were of minor clinical importance given the kinetic features of the bisphosphonates. In conclusion, both formulations afforded comparable bioavailability; that is to say that they can provide a sufficient amount of APD within the studied dose interval, so as to cause similar clinical effects.</description><identifier>ISSN: 0025-7680</identifier><identifier>PMID: 12325487</identifier><language>eng</language><publisher>Argentina</publisher><subject>Administration, Oral ; Adult ; Anti-Inflammatory Agents - pharmacokinetics ; Biological Availability ; Cross-Over Studies ; Diphosphonates - pharmacokinetics ; Female ; Gastrointestinal Agents - pharmacokinetics ; Humans ; Male ; Protective Agents - pharmacokinetics</subject><ispartof>Medicina (Buenos Aires), 2002, Vol.62 (4), p.317-322</ispartof><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,4024</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/12325487$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Roldán, Emilio J A</creatorcontrib><creatorcontrib>Quattrocchi, Oscar</creatorcontrib><creatorcontrib>Zanchetta, Jose</creatorcontrib><creatorcontrib>Plotkin, Horacio</creatorcontrib><creatorcontrib>Araujo, Graciela</creatorcontrib><creatorcontrib>Piccinni, Enrique</creatorcontrib><title>Comparable bioavailability of two esophago-gastric protective formulations containing pamidronate. A cross-over trial in healthy young adults</title><title>Medicina (Buenos Aires)</title><addtitle>Medicina (B Aires)</addtitle><description>The net absorbable amount of pamidronate (APD), according to AUC values assessed in blood, in the customary dose interval of 24 hours, was found to be similar in 8 healthy young volunteers, who received single doses of 3 capsules of 100 mg APD (AUC0-24 = 510.3 +/- 91.5 micrograms/L x h-1) and 2 tablets of 150 mg (AUC0-24 = 580.5 +/- 117.6 micrograms/L x h-1; p = 0.58) in the fasting state. Both formulations present acid-resistant coatings, designed to protect the mucosa of the upper digestive system from contact with insoluble particles of the bisphosphonates. Tmax values were different, and Cmax values presented a wide inter-individual variation, so that both formulations were not strictly bioequivalent. However, these latter factors were of minor clinical importance given the kinetic features of the bisphosphonates. In conclusion, both formulations afforded comparable bioavailability; that is to say that they can provide a sufficient amount of APD within the studied dose interval, so as to cause similar clinical effects.</description><subject>Administration, Oral</subject><subject>Adult</subject><subject>Anti-Inflammatory Agents - pharmacokinetics</subject><subject>Biological Availability</subject><subject>Cross-Over Studies</subject><subject>Diphosphonates - pharmacokinetics</subject><subject>Female</subject><subject>Gastrointestinal Agents - pharmacokinetics</subject><subject>Humans</subject><subject>Male</subject><subject>Protective Agents - pharmacokinetics</subject><issn>0025-7680</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2002</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo1kMtOwzAURLMA0VL4BeQVuyDHzqNeVhUvqRIbWEfXyXVr5OQG2wnKR_DPRKKsZnPmSDMXyZpzUaRVueWr5DqET86lqlR5lawyIUWRb6t18rOnbgAP2iHTlmAC60BbZ-PMyLD4TQwDDSc4UnqEEL1t2OApYhPthMyQ70YH0VIfWEN9BNvb_sgG6GzrqYeID2zHGk8hpDShZ4sBHLM9OyG4eJrZTONSgHZ0MdwklwZcwNtzbpKPp8f3_Ut6eHt-3e8O6ZBJFdNWtlKowoiS55kpRJPJUmdboZALI_PcCEBZCmNQQ5ErXlRcqxKUbqu2yQXITXL_512mfI0YYt3Z0KBz0CONoa5EJmXF8wW8O4Oj7rCtB2878HP9f6D8BZ0bb4M</recordid><startdate>2002</startdate><enddate>2002</enddate><creator>Roldán, Emilio J A</creator><creator>Quattrocchi, Oscar</creator><creator>Zanchetta, Jose</creator><creator>Plotkin, Horacio</creator><creator>Araujo, Graciela</creator><creator>Piccinni, Enrique</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>2002</creationdate><title>Comparable bioavailability of two esophago-gastric protective formulations containing pamidronate. 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A cross-over trial in healthy young adults</atitle><jtitle>Medicina (Buenos Aires)</jtitle><addtitle>Medicina (B Aires)</addtitle><date>2002</date><risdate>2002</risdate><volume>62</volume><issue>4</issue><spage>317</spage><epage>322</epage><pages>317-322</pages><issn>0025-7680</issn><abstract>The net absorbable amount of pamidronate (APD), according to AUC values assessed in blood, in the customary dose interval of 24 hours, was found to be similar in 8 healthy young volunteers, who received single doses of 3 capsules of 100 mg APD (AUC0-24 = 510.3 +/- 91.5 micrograms/L x h-1) and 2 tablets of 150 mg (AUC0-24 = 580.5 +/- 117.6 micrograms/L x h-1; p = 0.58) in the fasting state. Both formulations present acid-resistant coatings, designed to protect the mucosa of the upper digestive system from contact with insoluble particles of the bisphosphonates. Tmax values were different, and Cmax values presented a wide inter-individual variation, so that both formulations were not strictly bioequivalent. However, these latter factors were of minor clinical importance given the kinetic features of the bisphosphonates. In conclusion, both formulations afforded comparable bioavailability; that is to say that they can provide a sufficient amount of APD within the studied dose interval, so as to cause similar clinical effects.</abstract><cop>Argentina</cop><pmid>12325487</pmid><tpages>6</tpages></addata></record> |
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| ispartof | Medicina (Buenos Aires), 2002, Vol.62 (4), p.317-322 |
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| language | eng |
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| source | MEDLINE; EZB-FREE-00999 freely available EZB journals |
| subjects | Administration, Oral Adult Anti-Inflammatory Agents - pharmacokinetics Biological Availability Cross-Over Studies Diphosphonates - pharmacokinetics Female Gastrointestinal Agents - pharmacokinetics Humans Male Protective Agents - pharmacokinetics |
| title | Comparable bioavailability of two esophago-gastric protective formulations containing pamidronate. A cross-over trial in healthy young adults |
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