Pharmacokinetics of Lacosamide in Healthy Korean Male Volunteers
Aim: The aim of this study was to evaluate the pharmacokinetics (PK) of single and repeated doses of lacosamide in healthy male Korean volunteers and to compare the PK profile of lacosamide in Korean and Caucasian populations. Methods: In a double-blind, placebo-controlled, parallel-group, dose-esca...
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| Veröffentlicht in: | Pharmacology 2012-01, Vol.89 (3-4), p.172-178 |
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| creator | Kim, Sung Eun Gu, Namyi Kim, Bo-Hyung Fitchner, Andreas Elshoff, Jan-Peer Cawello, Willi Jang, In-Jin Yu, Kyung-Sang |
| description | Aim: The aim of this study was to evaluate the pharmacokinetics (PK) of single and repeated doses of lacosamide in healthy male Korean volunteers and to compare the PK profile of lacosamide in Korean and Caucasian populations. Methods: In a double-blind, placebo-controlled, parallel-group, dose-escalation trial, 16 volunteers received a single dose (50 mg) of lacosamide or placebo, and 32 volunteers were administered single/repeated twice-daily doses (100 or 200 mg) of lacosamide or placebo. Results: For multiple doses of 100 and 200 mg twice daily, the geometric means C max,ss were 6.23 (15.0) and 13.13 (8.9) µg/ml respectively, and AUC τ ,s s values were 52.10 (17.0) and 112.35 (13.0) µg·h/ml, respectively. Values for both parameters were relatively higher than those seen in Caucasians. To further describe ethnic differences, population PK analysis was assessed. A one-compartment model with first-order absorption and elimination was selected and effects of CL creatinine on CL/F and body surface area on V/F were included in the final model. Conclusion: There were no other ethnic differences in the PK profile of lacosamide between Koreans and Caucasians based on the population PK analysis, except for the demographic differences. |
| doi_str_mv | 10.1159/000336774 |
| format | Article |
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Methods: In a double-blind, placebo-controlled, parallel-group, dose-escalation trial, 16 volunteers received a single dose (50 mg) of lacosamide or placebo, and 32 volunteers were administered single/repeated twice-daily doses (100 or 200 mg) of lacosamide or placebo. Results: For multiple doses of 100 and 200 mg twice daily, the geometric means C max,ss were 6.23 (15.0) and 13.13 (8.9) µg/ml respectively, and AUC τ ,s s values were 52.10 (17.0) and 112.35 (13.0) µg·h/ml, respectively. Values for both parameters were relatively higher than those seen in Caucasians. To further describe ethnic differences, population PK analysis was assessed. A one-compartment model with first-order absorption and elimination was selected and effects of CL creatinine on CL/F and body surface area on V/F were included in the final model. Conclusion: There were no other ethnic differences in the PK profile of lacosamide between Koreans and Caucasians based on the population PK analysis, except for the demographic differences.</description><identifier>ISSN: 0031-7012</identifier><identifier>EISSN: 1423-0313</identifier><identifier>DOI: 10.1159/000336774</identifier><identifier>PMID: 22437449</identifier><language>eng</language><publisher>Basel, Switzerland: S. Karger AG</publisher><subject>Acetamides - administration & dosage ; Acetamides - blood ; Acetamides - pharmacokinetics ; Adult ; Anticonvulsants - administration & dosage ; Anticonvulsants - blood ; Anticonvulsants - pharmacokinetics ; Area Under Curve ; Asian Continental Ancestry Group ; Asian people ; Bioavailability ; Clinical outcomes ; Clinical trials ; Double-Blind Method ; Epilepsy ; European Continental Ancestry Group ; Humans ; Male ; Men ; Original Paper ; Pharmacology ; Young Adult</subject><ispartof>Pharmacology, 2012-01, Vol.89 (3-4), p.172-178</ispartof><rights>2012 S. Karger AG, Basel</rights><rights>Copyright © 2012 S. Karger AG, Basel.</rights><rights>Copyright (c) 2012 S. Karger AG, Basel</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c400t-1c53bf21ac2969a0d82d67da28d1ecdb7967a555f97c79ca89cae6f558df89643</citedby><cites>FETCH-LOGICAL-c400t-1c53bf21ac2969a0d82d67da28d1ecdb7967a555f97c79ca89cae6f558df89643</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,2423,27903,27904</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22437449$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kim, Sung Eun</creatorcontrib><creatorcontrib>Gu, Namyi</creatorcontrib><creatorcontrib>Kim, Bo-Hyung</creatorcontrib><creatorcontrib>Fitchner, Andreas</creatorcontrib><creatorcontrib>Elshoff, Jan-Peer</creatorcontrib><creatorcontrib>Cawello, Willi</creatorcontrib><creatorcontrib>Jang, In-Jin</creatorcontrib><creatorcontrib>Yu, Kyung-Sang</creatorcontrib><title>Pharmacokinetics of Lacosamide in Healthy Korean Male Volunteers</title><title>Pharmacology</title><addtitle>Pharmacology</addtitle><description>Aim: The aim of this study was to evaluate the pharmacokinetics (PK) of single and repeated doses of lacosamide in healthy male Korean volunteers and to compare the PK profile of lacosamide in Korean and Caucasian populations. Methods: In a double-blind, placebo-controlled, parallel-group, dose-escalation trial, 16 volunteers received a single dose (50 mg) of lacosamide or placebo, and 32 volunteers were administered single/repeated twice-daily doses (100 or 200 mg) of lacosamide or placebo. Results: For multiple doses of 100 and 200 mg twice daily, the geometric means C max,ss were 6.23 (15.0) and 13.13 (8.9) µg/ml respectively, and AUC τ ,s s values were 52.10 (17.0) and 112.35 (13.0) µg·h/ml, respectively. Values for both parameters were relatively higher than those seen in Caucasians. To further describe ethnic differences, population PK analysis was assessed. A one-compartment model with first-order absorption and elimination was selected and effects of CL creatinine on CL/F and body surface area on V/F were included in the final model. Conclusion: There were no other ethnic differences in the PK profile of lacosamide between Koreans and Caucasians based on the population PK analysis, except for the demographic differences.</description><subject>Acetamides - administration & dosage</subject><subject>Acetamides - blood</subject><subject>Acetamides - pharmacokinetics</subject><subject>Adult</subject><subject>Anticonvulsants - administration & dosage</subject><subject>Anticonvulsants - blood</subject><subject>Anticonvulsants - pharmacokinetics</subject><subject>Area Under Curve</subject><subject>Asian Continental Ancestry Group</subject><subject>Asian people</subject><subject>Bioavailability</subject><subject>Clinical outcomes</subject><subject>Clinical trials</subject><subject>Double-Blind Method</subject><subject>Epilepsy</subject><subject>European Continental Ancestry Group</subject><subject>Humans</subject><subject>Male</subject><subject>Men</subject><subject>Original Paper</subject><subject>Pharmacology</subject><subject>Young Adult</subject><issn>0031-7012</issn><issn>1423-0313</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNpd0DtPwzAUBWALgWgpDOwIRWKBIeBX7HgDVUARRTAAa-TaNzRtEhc7GfrvMWrpwGBd-erzkXUQOiX4mpBM3WCMGRNS8j00JJyyFDPC9tEwrkkqMaEDdBTCIjJBZX6IBpRyJjlXQ3T7Nte-0cYtqxa6yoTElck03oNuKgtJ1SYT0HU3XyfPzoNukxddQ_Lp6r7tAHw4RgelrgOcbOcIfTzcv48n6fT18Wl8N00Nx7hLicnYrKREG6qE0tjm1AppNc0tAWNnUgmpsywrlTRSGZ3HA6LMstyWuRKcjdDlJnfl3XcPoSuaKhioa92C60NBMCFEKZ7LSC_-0YXrfRt_FxWVWGDJRFRXG2W8C8FDWax81Wi_jqj4rbXY1Rrt-TaxnzVgd_KvxwjONmCp_Rf4Hdi-_wGFt3lk</recordid><startdate>20120101</startdate><enddate>20120101</enddate><creator>Kim, Sung Eun</creator><creator>Gu, Namyi</creator><creator>Kim, Bo-Hyung</creator><creator>Fitchner, Andreas</creator><creator>Elshoff, Jan-Peer</creator><creator>Cawello, Willi</creator><creator>Jang, In-Jin</creator><creator>Yu, Kyung-Sang</creator><general>S. Karger AG</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>3V.</scope><scope>7RV</scope><scope>7TK</scope><scope>7U7</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20120101</creationdate><title>Pharmacokinetics of Lacosamide in Healthy Korean Male Volunteers</title><author>Kim, Sung Eun ; Gu, Namyi ; Kim, Bo-Hyung ; Fitchner, Andreas ; Elshoff, Jan-Peer ; Cawello, Willi ; Jang, In-Jin ; Yu, Kyung-Sang</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c400t-1c53bf21ac2969a0d82d67da28d1ecdb7967a555f97c79ca89cae6f558df89643</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Acetamides - administration & dosage</topic><topic>Acetamides - blood</topic><topic>Acetamides - pharmacokinetics</topic><topic>Adult</topic><topic>Anticonvulsants - administration & dosage</topic><topic>Anticonvulsants - blood</topic><topic>Anticonvulsants - pharmacokinetics</topic><topic>Area Under Curve</topic><topic>Asian Continental Ancestry Group</topic><topic>Asian people</topic><topic>Bioavailability</topic><topic>Clinical outcomes</topic><topic>Clinical trials</topic><topic>Double-Blind Method</topic><topic>Epilepsy</topic><topic>European Continental Ancestry Group</topic><topic>Humans</topic><topic>Male</topic><topic>Men</topic><topic>Original Paper</topic><topic>Pharmacology</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kim, Sung Eun</creatorcontrib><creatorcontrib>Gu, Namyi</creatorcontrib><creatorcontrib>Kim, Bo-Hyung</creatorcontrib><creatorcontrib>Fitchner, Andreas</creatorcontrib><creatorcontrib>Elshoff, Jan-Peer</creatorcontrib><creatorcontrib>Cawello, Willi</creatorcontrib><creatorcontrib>Jang, In-Jin</creatorcontrib><creatorcontrib>Yu, Kyung-Sang</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>Pharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kim, Sung Eun</au><au>Gu, Namyi</au><au>Kim, Bo-Hyung</au><au>Fitchner, Andreas</au><au>Elshoff, Jan-Peer</au><au>Cawello, Willi</au><au>Jang, In-Jin</au><au>Yu, Kyung-Sang</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pharmacokinetics of Lacosamide in Healthy Korean Male Volunteers</atitle><jtitle>Pharmacology</jtitle><addtitle>Pharmacology</addtitle><date>2012-01-01</date><risdate>2012</risdate><volume>89</volume><issue>3-4</issue><spage>172</spage><epage>178</epage><pages>172-178</pages><issn>0031-7012</issn><eissn>1423-0313</eissn><abstract>Aim: The aim of this study was to evaluate the pharmacokinetics (PK) of single and repeated doses of lacosamide in healthy male Korean volunteers and to compare the PK profile of lacosamide in Korean and Caucasian populations. Methods: In a double-blind, placebo-controlled, parallel-group, dose-escalation trial, 16 volunteers received a single dose (50 mg) of lacosamide or placebo, and 32 volunteers were administered single/repeated twice-daily doses (100 or 200 mg) of lacosamide or placebo. Results: For multiple doses of 100 and 200 mg twice daily, the geometric means C max,ss were 6.23 (15.0) and 13.13 (8.9) µg/ml respectively, and AUC τ ,s s values were 52.10 (17.0) and 112.35 (13.0) µg·h/ml, respectively. Values for both parameters were relatively higher than those seen in Caucasians. To further describe ethnic differences, population PK analysis was assessed. A one-compartment model with first-order absorption and elimination was selected and effects of CL creatinine on CL/F and body surface area on V/F were included in the final model. Conclusion: There were no other ethnic differences in the PK profile of lacosamide between Koreans and Caucasians based on the population PK analysis, except for the demographic differences.</abstract><cop>Basel, Switzerland</cop><pub>S. Karger AG</pub><pmid>22437449</pmid><doi>10.1159/000336774</doi><tpages>7</tpages></addata></record> |
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| ispartof | Pharmacology, 2012-01, Vol.89 (3-4), p.172-178 |
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| language | eng |
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| source | Karger Journals; MEDLINE; Alma/SFX Local Collection |
| subjects | Acetamides - administration & dosage Acetamides - blood Acetamides - pharmacokinetics Adult Anticonvulsants - administration & dosage Anticonvulsants - blood Anticonvulsants - pharmacokinetics Area Under Curve Asian Continental Ancestry Group Asian people Bioavailability Clinical outcomes Clinical trials Double-Blind Method Epilepsy European Continental Ancestry Group Humans Male Men Original Paper Pharmacology Young Adult |
| title | Pharmacokinetics of Lacosamide in Healthy Korean Male Volunteers |
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