A Single-Dose, Two-Way Crossover, Open-Label Bioequivalence Study of an Amphetamine Extended-Release Oral Suspension in Healthy Adults
Objective: The purpose of this study was to compare the pharmacokinetics of a new extended-release amphetamine oral suspension (AMP XR-OS) with a standard extended-release mixed amphetamine salts product, Adderall XR®. Method: In this single-dose, open-label, randomized, two-period, two-treatment cr...
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| Veröffentlicht in: | Journal of attention disorders 2020-02, Vol.24 (3), p.414-419 |
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| container_title | Journal of attention disorders |
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| creator | Sikes, Carolyn Stark, Jeffrey G. McMahen, Russ Engelking, Dorothy |
| description | Objective: The purpose of this study was to compare the pharmacokinetics of a new extended-release amphetamine oral suspension (AMP XR-OS) with a standard extended-release mixed amphetamine salts product, Adderall XR®. Method: In this single-dose, open-label, randomized, two-period, two-treatment crossover study, 42 healthy adult volunteers received 15 mL of AMP XR-OS in one period and a 30 mg Adderall XR capsule in another period (both containing 18.8 mg of amphetamine base) under fasted conditions. Blood samples were analyzed for
d
- and
l
-amphetamine concentrations, and pharmacokinetic parameters Cmax, AUC0-5, AUC5-last, and AUCinf were calculated to determine bioequivalence. Safety was monitored throughout the study. Results: The 90% confidence intervals (CIs) for the log-transformed Cmax, AUC0-5, AUC5-last, and AUCinf fell within the accepted 80% to 125% range for establishing bioequivalence for
d
- and
l
-amphetamine. The most common adverse events were nausea and decreased appetite. Conclusion: AMP XR-OS is bioequivalent to Adderall XR in healthy adult participants. |
| doi_str_mv | 10.1177/1087054717743329 |
| format | Article |
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d
- and
l
-amphetamine concentrations, and pharmacokinetic parameters Cmax, AUC0-5, AUC5-last, and AUCinf were calculated to determine bioequivalence. Safety was monitored throughout the study. Results: The 90% confidence intervals (CIs) for the log-transformed Cmax, AUC0-5, AUC5-last, and AUCinf fell within the accepted 80% to 125% range for establishing bioequivalence for
d
- and
l
-amphetamine. The most common adverse events were nausea and decreased appetite. Conclusion: AMP XR-OS is bioequivalent to Adderall XR in healthy adult participants.</description><identifier>ISSN: 1087-0547</identifier><identifier>EISSN: 1557-1246</identifier><identifier>DOI: 10.1177/1087054717743329</identifier><identifier>PMID: 29192549</identifier><language>eng</language><publisher>Los Angeles, CA: SAGE Publications</publisher><subject>Administration, Oral ; Adult ; Amphetamine - adverse effects ; Attention Deficit Disorder with Hyperactivity - drug therapy ; Cross-Over Studies ; Delayed-Action Preparations - therapeutic use ; Humans ; Therapeutic Equivalency</subject><ispartof>Journal of attention disorders, 2020-02, Vol.24 (3), p.414-419</ispartof><rights>The Author(s) 2017</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c477t-4d466c28ae93b40f2c333dd5c681fedda0c2ed1b2b8630e8b76745b3a9d6527d3</citedby><cites>FETCH-LOGICAL-c477t-4d466c28ae93b40f2c333dd5c681fedda0c2ed1b2b8630e8b76745b3a9d6527d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://journals.sagepub.com/doi/pdf/10.1177/1087054717743329$$EPDF$$P50$$Gsage$$H</linktopdf><linktohtml>$$Uhttps://journals.sagepub.com/doi/10.1177/1087054717743329$$EHTML$$P50$$Gsage$$H</linktohtml><link.rule.ids>314,776,780,21798,27901,27902,43597,43598</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29192549$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sikes, Carolyn</creatorcontrib><creatorcontrib>Stark, Jeffrey G.</creatorcontrib><creatorcontrib>McMahen, Russ</creatorcontrib><creatorcontrib>Engelking, Dorothy</creatorcontrib><title>A Single-Dose, Two-Way Crossover, Open-Label Bioequivalence Study of an Amphetamine Extended-Release Oral Suspension in Healthy Adults</title><title>Journal of attention disorders</title><addtitle>J Atten Disord</addtitle><description>Objective: The purpose of this study was to compare the pharmacokinetics of a new extended-release amphetamine oral suspension (AMP XR-OS) with a standard extended-release mixed amphetamine salts product, Adderall XR®. Method: In this single-dose, open-label, randomized, two-period, two-treatment crossover study, 42 healthy adult volunteers received 15 mL of AMP XR-OS in one period and a 30 mg Adderall XR capsule in another period (both containing 18.8 mg of amphetamine base) under fasted conditions. Blood samples were analyzed for
d
- and
l
-amphetamine concentrations, and pharmacokinetic parameters Cmax, AUC0-5, AUC5-last, and AUCinf were calculated to determine bioequivalence. Safety was monitored throughout the study. Results: The 90% confidence intervals (CIs) for the log-transformed Cmax, AUC0-5, AUC5-last, and AUCinf fell within the accepted 80% to 125% range for establishing bioequivalence for
d
- and
l
-amphetamine. The most common adverse events were nausea and decreased appetite. Conclusion: AMP XR-OS is bioequivalent to Adderall XR in healthy adult participants.</description><subject>Administration, Oral</subject><subject>Adult</subject><subject>Amphetamine - adverse effects</subject><subject>Attention Deficit Disorder with Hyperactivity - drug therapy</subject><subject>Cross-Over Studies</subject><subject>Delayed-Action Preparations - therapeutic use</subject><subject>Humans</subject><subject>Therapeutic Equivalency</subject><issn>1087-0547</issn><issn>1557-1246</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1UM1Kw0AYXESxWr17kn2Aru5fsskx1mqFQsFWPIZN9kubkmxqNqnmBXxuU6oeBE8zMD8wg9AVozeMKXXLaKCoJ1XPpRA8PEJnzPMUYVz6xz3vZbLXB-jcuQ2lQinFT9GAhyzkngzP0GeEF7ldFUDuKwcjvHyvyKvu8LiunKt2UI_wfAuWzHQCBb7LK3hr850uwKaAF01rOlxlWFsclds1NLrMLeDJRwPWgCHPUIB2gOe1LvCidX2TyyuLc4unoItm3eHItEXjLtBJpgsHl984RC8Pk-V4Smbzx6dxNCOpVKoh0kjfT3mgIRSJpBlPhRDGeKkfsAyM0TTlYFjCk8AXFIJE-Up6idCh8T2ujBgieuhN9_tqyOJtnZe67mJG4_2l8d9L-8j1IbJtkxLMb-Dnw95ADganVxBvqra2_YT_C78A-CR_Vw</recordid><startdate>20200201</startdate><enddate>20200201</enddate><creator>Sikes, Carolyn</creator><creator>Stark, Jeffrey G.</creator><creator>McMahen, Russ</creator><creator>Engelking, Dorothy</creator><general>SAGE Publications</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></search><sort><creationdate>20200201</creationdate><title>A Single-Dose, Two-Way Crossover, Open-Label Bioequivalence Study of an Amphetamine Extended-Release Oral Suspension in Healthy Adults</title><author>Sikes, Carolyn ; Stark, Jeffrey G. ; McMahen, Russ ; Engelking, Dorothy</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c477t-4d466c28ae93b40f2c333dd5c681fedda0c2ed1b2b8630e8b76745b3a9d6527d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Administration, Oral</topic><topic>Adult</topic><topic>Amphetamine - adverse effects</topic><topic>Attention Deficit Disorder with Hyperactivity - drug therapy</topic><topic>Cross-Over Studies</topic><topic>Delayed-Action Preparations - therapeutic use</topic><topic>Humans</topic><topic>Therapeutic Equivalency</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sikes, Carolyn</creatorcontrib><creatorcontrib>Stark, Jeffrey G.</creatorcontrib><creatorcontrib>McMahen, Russ</creatorcontrib><creatorcontrib>Engelking, Dorothy</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><jtitle>Journal of attention disorders</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sikes, Carolyn</au><au>Stark, Jeffrey G.</au><au>McMahen, Russ</au><au>Engelking, Dorothy</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Single-Dose, Two-Way Crossover, Open-Label Bioequivalence Study of an Amphetamine Extended-Release Oral Suspension in Healthy Adults</atitle><jtitle>Journal of attention disorders</jtitle><addtitle>J Atten Disord</addtitle><date>2020-02-01</date><risdate>2020</risdate><volume>24</volume><issue>3</issue><spage>414</spage><epage>419</epage><pages>414-419</pages><issn>1087-0547</issn><eissn>1557-1246</eissn><abstract>Objective: The purpose of this study was to compare the pharmacokinetics of a new extended-release amphetamine oral suspension (AMP XR-OS) with a standard extended-release mixed amphetamine salts product, Adderall XR®. Method: In this single-dose, open-label, randomized, two-period, two-treatment crossover study, 42 healthy adult volunteers received 15 mL of AMP XR-OS in one period and a 30 mg Adderall XR capsule in another period (both containing 18.8 mg of amphetamine base) under fasted conditions. Blood samples were analyzed for
d
- and
l
-amphetamine concentrations, and pharmacokinetic parameters Cmax, AUC0-5, AUC5-last, and AUCinf were calculated to determine bioequivalence. Safety was monitored throughout the study. Results: The 90% confidence intervals (CIs) for the log-transformed Cmax, AUC0-5, AUC5-last, and AUCinf fell within the accepted 80% to 125% range for establishing bioequivalence for
d
- and
l
-amphetamine. The most common adverse events were nausea and decreased appetite. Conclusion: AMP XR-OS is bioequivalent to Adderall XR in healthy adult participants.</abstract><cop>Los Angeles, CA</cop><pub>SAGE Publications</pub><pmid>29192549</pmid><doi>10.1177/1087054717743329</doi><tpages>6</tpages></addata></record> |
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| identifier | ISSN: 1087-0547 |
| ispartof | Journal of attention disorders, 2020-02, Vol.24 (3), p.414-419 |
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| language | eng |
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| source | SAGE Complete A-Z List; MEDLINE |
| subjects | Administration, Oral Adult Amphetamine - adverse effects Attention Deficit Disorder with Hyperactivity - drug therapy Cross-Over Studies Delayed-Action Preparations - therapeutic use Humans Therapeutic Equivalency |
| title | A Single-Dose, Two-Way Crossover, Open-Label Bioequivalence Study of an Amphetamine Extended-Release Oral Suspension in Healthy Adults |
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