Systemic exposure to benzoic acid and hippuric acid following topical application of clindamycin 1%/benzoyl peroxide 3% fixed-dose combination gel in Japanese patients with acne vulgaris
Clindamycin 1%/benzoyl peroxide 3% fixed‐dose combination gel (CLDM/BPO3%) is a topical product for the treatment of acne vulgaris. In this study, plasma and urine concentrations of benzoic acid (BA) and hippuric acid (HA) were analyzed to estimate the pharmacokinetics (PK) of BPO after application...
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| Veröffentlicht in: | Clinical pharmacology in drug development 2015-01, Vol.4 (1), p.18-24 |
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| creator | Ino, Hiroko Takahashi, Naoki Saenz, Alessandra Alio Wakamatsu, Akira Hashimoto, Hirofumi Nakahara, Norie Hasegawa, Setsuo |
| description | Clindamycin 1%/benzoyl peroxide 3% fixed‐dose combination gel (CLDM/BPO3%) is a topical product for the treatment of acne vulgaris. In this study, plasma and urine concentrations of benzoic acid (BA) and hippuric acid (HA) were analyzed to estimate the pharmacokinetics (PK) of BPO after application of CLDM/BPO3% twice‐daily for 7 days in Japanese patients with acne vulgaris. Seven‐day repeated application of CLDM/BPO3% appears to be safe in this patient population. Concentrations of plasma and urine BA were below the limit of quantification before and after repeated application in most of the 12 adult male patients. Mean difference in Cmax and AUC0–last for plasma HA indicated increased exposures after repeated application, but with wide 90% confidence intervals. Mean Ae0–12 for urine HA was similar before and after repeated application. Repeated application of CLDM/BPO3% is thus unlikely to result in accumulation of BA and HA. The study suggests negligible systemic exposure to BPO metabolites from CLDM/BPO3% after 7‐day repeated application in male patients with acne vulgaris. |
| doi_str_mv | 10.1002/cpdd.125 |
| format | Article |
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In this study, plasma and urine concentrations of benzoic acid (BA) and hippuric acid (HA) were analyzed to estimate the pharmacokinetics (PK) of BPO after application of CLDM/BPO3% twice‐daily for 7 days in Japanese patients with acne vulgaris. Seven‐day repeated application of CLDM/BPO3% appears to be safe in this patient population. Concentrations of plasma and urine BA were below the limit of quantification before and after repeated application in most of the 12 adult male patients. Mean difference in Cmax and AUC0–last for plasma HA indicated increased exposures after repeated application, but with wide 90% confidence intervals. Mean Ae0–12 for urine HA was similar before and after repeated application. Repeated application of CLDM/BPO3% is thus unlikely to result in accumulation of BA and HA. The study suggests negligible systemic exposure to BPO metabolites from CLDM/BPO3% after 7‐day repeated application in male patients with acne vulgaris.</description><identifier>ISSN: 2160-763X</identifier><identifier>EISSN: 2160-7648</identifier><identifier>DOI: 10.1002/cpdd.125</identifier><identifier>PMID: 27128000</identifier><language>eng</language><publisher>United States: Blackwell Publishing Ltd</publisher><subject>Acids ; Acne ; acne vulgaris ; Acne Vulgaris - blood ; Acne Vulgaris - diagnosis ; Acne Vulgaris - drug therapy ; Acne Vulgaris - ethnology ; Administration, Cutaneous ; Adult ; Anti-Bacterial Agents - administration & dosage ; Anti-Bacterial Agents - adverse effects ; Anti-Bacterial Agents - pharmacokinetics ; Area Under Curve ; Asian Continental Ancestry Group ; benzoic acid ; Benzoic Acid - blood ; Benzoic Acid - pharmacokinetics ; Benzoic Acid - urine ; benzoyl peroxide ; Benzoyl Peroxide - administration & dosage ; Benzoyl Peroxide - adverse effects ; Benzoyl Peroxide - pharmacokinetics ; Biotransformation ; Birth control ; Clindamycin - administration & dosage ; Clindamycin - adverse effects ; Clindamycin - pharmacokinetics ; Confidence intervals ; Dermatologic Agents - administration & dosage ; Dermatologic Agents - adverse effects ; Dermatologic Agents - pharmacokinetics ; Drug Administration Schedule ; Drug Combinations ; Drug Monitoring - methods ; Hippurates - blood ; Hippurates - pharmacokinetics ; Hippurates - urine ; hippuric acid ; Humans ; Japan ; Male ; Metabolic Clearance Rate ; pharmacokinetics ; Prescription drugs ; Urine ; Young Adult</subject><ispartof>Clinical pharmacology in drug development, 2015-01, Vol.4 (1), p.18-24</ispartof><rights>2014, The American College of Clinical Pharmacology</rights><rights>2014, The American College of Clinical Pharmacology.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4205-5506525b6f68bacc1e8dade0a03bdda992b63ee33b3a68589bc3f9acd8359bb43</citedby><cites>FETCH-LOGICAL-c4205-5506525b6f68bacc1e8dade0a03bdda992b63ee33b3a68589bc3f9acd8359bb43</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fcpdd.125$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fcpdd.125$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27128000$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ino, Hiroko</creatorcontrib><creatorcontrib>Takahashi, Naoki</creatorcontrib><creatorcontrib>Saenz, Alessandra Alio</creatorcontrib><creatorcontrib>Wakamatsu, Akira</creatorcontrib><creatorcontrib>Hashimoto, Hirofumi</creatorcontrib><creatorcontrib>Nakahara, Norie</creatorcontrib><creatorcontrib>Hasegawa, Setsuo</creatorcontrib><title>Systemic exposure to benzoic acid and hippuric acid following topical application of clindamycin 1%/benzoyl peroxide 3% fixed-dose combination gel in Japanese patients with acne vulgaris</title><title>Clinical pharmacology in drug development</title><addtitle>Clin Pharmacol Drug Dev</addtitle><description>Clindamycin 1%/benzoyl peroxide 3% fixed‐dose combination gel (CLDM/BPO3%) is a topical product for the treatment of acne vulgaris. In this study, plasma and urine concentrations of benzoic acid (BA) and hippuric acid (HA) were analyzed to estimate the pharmacokinetics (PK) of BPO after application of CLDM/BPO3% twice‐daily for 7 days in Japanese patients with acne vulgaris. Seven‐day repeated application of CLDM/BPO3% appears to be safe in this patient population. Concentrations of plasma and urine BA were below the limit of quantification before and after repeated application in most of the 12 adult male patients. Mean difference in Cmax and AUC0–last for plasma HA indicated increased exposures after repeated application, but with wide 90% confidence intervals. Mean Ae0–12 for urine HA was similar before and after repeated application. Repeated application of CLDM/BPO3% is thus unlikely to result in accumulation of BA and HA. The study suggests negligible systemic exposure to BPO metabolites from CLDM/BPO3% after 7‐day repeated application in male patients with acne vulgaris.</description><subject>Acids</subject><subject>Acne</subject><subject>acne vulgaris</subject><subject>Acne Vulgaris - blood</subject><subject>Acne Vulgaris - diagnosis</subject><subject>Acne Vulgaris - drug therapy</subject><subject>Acne Vulgaris - ethnology</subject><subject>Administration, Cutaneous</subject><subject>Adult</subject><subject>Anti-Bacterial Agents - administration & dosage</subject><subject>Anti-Bacterial Agents - adverse effects</subject><subject>Anti-Bacterial Agents - pharmacokinetics</subject><subject>Area Under Curve</subject><subject>Asian Continental Ancestry Group</subject><subject>benzoic acid</subject><subject>Benzoic Acid - blood</subject><subject>Benzoic Acid - pharmacokinetics</subject><subject>Benzoic Acid - urine</subject><subject>benzoyl peroxide</subject><subject>Benzoyl Peroxide - administration & dosage</subject><subject>Benzoyl Peroxide - adverse effects</subject><subject>Benzoyl Peroxide - pharmacokinetics</subject><subject>Biotransformation</subject><subject>Birth control</subject><subject>Clindamycin - administration & dosage</subject><subject>Clindamycin - adverse effects</subject><subject>Clindamycin - pharmacokinetics</subject><subject>Confidence intervals</subject><subject>Dermatologic Agents - administration & dosage</subject><subject>Dermatologic Agents - adverse effects</subject><subject>Dermatologic Agents - pharmacokinetics</subject><subject>Drug Administration Schedule</subject><subject>Drug Combinations</subject><subject>Drug Monitoring - methods</subject><subject>Hippurates - blood</subject><subject>Hippurates - pharmacokinetics</subject><subject>Hippurates - urine</subject><subject>hippuric acid</subject><subject>Humans</subject><subject>Japan</subject><subject>Male</subject><subject>Metabolic Clearance Rate</subject><subject>pharmacokinetics</subject><subject>Prescription drugs</subject><subject>Urine</subject><subject>Young Adult</subject><issn>2160-763X</issn><issn>2160-7648</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kd9qFDEUxgdRbKkFn0ACUvBm2mSyycxc6ta2StWCir0L-XNmm5qZxGTG3e2j-XSm7nYFwXNzDl9-58uBryieE3xMMK5OdDDmmFTsUbFfEY7Lms-ax7uZXu8Vhynd4lwcE0JmT4u9qiZVk4X94tfndRqhtxrBKvg0RUCjRwqGO581qa1BcjDoxoYwxQel8875pR0WmQ1WS4dkCC4Po_UD8h3Szg5G9mttB0SOTv7YrR0KEP3KGkD0CHV2BaY0PgHSvld22CwvwKG89F4GOUB-C1mGYUxoaceb_PsA6OfkFjLa9Kx40kmX4HDbD4qvZ2-_zC_Ky0_n7-avL0s9qzArGcOcVUzxjjdKak2gMdIAlpgqY2TbVopTAEoVlbxhTas07VqpTUNZq9SMHhSvNr4h-h8TpFH0NmlwLl_opyRI3bCaVTVvM_ryH_TWT3HI12WK0aZlbdv8NdTRpxShEyHaXsa1IFjcRyruIxU50oy-2BpOqgezAx8CzEC5AZbWwfq_RmJ-dXq6MdzyNse-2vEyfhe8pjUT3z6ei6v2jPE31x8Epr8BJAK9UQ</recordid><startdate>201501</startdate><enddate>201501</enddate><creator>Ino, Hiroko</creator><creator>Takahashi, Naoki</creator><creator>Saenz, Alessandra Alio</creator><creator>Wakamatsu, Akira</creator><creator>Hashimoto, Hirofumi</creator><creator>Nakahara, Norie</creator><creator>Hasegawa, Setsuo</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><scope>BSCLL</scope><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>K9.</scope><scope>7X8</scope></search><sort><creationdate>201501</creationdate><title>Systemic exposure to benzoic acid and hippuric acid following topical application of clindamycin 1%/benzoyl peroxide 3% fixed-dose combination gel in Japanese patients with acne vulgaris</title><author>Ino, Hiroko ; Takahashi, Naoki ; Saenz, Alessandra Alio ; Wakamatsu, Akira ; Hashimoto, Hirofumi ; Nakahara, Norie ; Hasegawa, Setsuo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4205-5506525b6f68bacc1e8dade0a03bdda992b63ee33b3a68589bc3f9acd8359bb43</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Acids</topic><topic>Acne</topic><topic>acne vulgaris</topic><topic>Acne Vulgaris - blood</topic><topic>Acne Vulgaris - diagnosis</topic><topic>Acne Vulgaris - drug therapy</topic><topic>Acne Vulgaris - ethnology</topic><topic>Administration, Cutaneous</topic><topic>Adult</topic><topic>Anti-Bacterial Agents - administration & dosage</topic><topic>Anti-Bacterial Agents - adverse effects</topic><topic>Anti-Bacterial Agents - pharmacokinetics</topic><topic>Area Under Curve</topic><topic>Asian Continental Ancestry Group</topic><topic>benzoic acid</topic><topic>Benzoic Acid - blood</topic><topic>Benzoic Acid - pharmacokinetics</topic><topic>Benzoic Acid - urine</topic><topic>benzoyl peroxide</topic><topic>Benzoyl Peroxide - administration & dosage</topic><topic>Benzoyl Peroxide - adverse effects</topic><topic>Benzoyl Peroxide - pharmacokinetics</topic><topic>Biotransformation</topic><topic>Birth control</topic><topic>Clindamycin - administration & dosage</topic><topic>Clindamycin - adverse effects</topic><topic>Clindamycin - pharmacokinetics</topic><topic>Confidence intervals</topic><topic>Dermatologic Agents - administration & dosage</topic><topic>Dermatologic Agents - adverse effects</topic><topic>Dermatologic Agents - pharmacokinetics</topic><topic>Drug Administration Schedule</topic><topic>Drug Combinations</topic><topic>Drug Monitoring - methods</topic><topic>Hippurates - blood</topic><topic>Hippurates - pharmacokinetics</topic><topic>Hippurates - urine</topic><topic>hippuric acid</topic><topic>Humans</topic><topic>Japan</topic><topic>Male</topic><topic>Metabolic Clearance Rate</topic><topic>pharmacokinetics</topic><topic>Prescription drugs</topic><topic>Urine</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ino, Hiroko</creatorcontrib><creatorcontrib>Takahashi, Naoki</creatorcontrib><creatorcontrib>Saenz, Alessandra Alio</creatorcontrib><creatorcontrib>Wakamatsu, Akira</creatorcontrib><creatorcontrib>Hashimoto, Hirofumi</creatorcontrib><creatorcontrib>Nakahara, Norie</creatorcontrib><creatorcontrib>Hasegawa, Setsuo</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical pharmacology in drug development</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ino, Hiroko</au><au>Takahashi, Naoki</au><au>Saenz, Alessandra Alio</au><au>Wakamatsu, Akira</au><au>Hashimoto, Hirofumi</au><au>Nakahara, Norie</au><au>Hasegawa, Setsuo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Systemic exposure to benzoic acid and hippuric acid following topical application of clindamycin 1%/benzoyl peroxide 3% fixed-dose combination gel in Japanese patients with acne vulgaris</atitle><jtitle>Clinical pharmacology in drug development</jtitle><addtitle>Clin Pharmacol Drug Dev</addtitle><date>2015-01</date><risdate>2015</risdate><volume>4</volume><issue>1</issue><spage>18</spage><epage>24</epage><pages>18-24</pages><issn>2160-763X</issn><eissn>2160-7648</eissn><abstract>Clindamycin 1%/benzoyl peroxide 3% fixed‐dose combination gel (CLDM/BPO3%) is a topical product for the treatment of acne vulgaris. In this study, plasma and urine concentrations of benzoic acid (BA) and hippuric acid (HA) were analyzed to estimate the pharmacokinetics (PK) of BPO after application of CLDM/BPO3% twice‐daily for 7 days in Japanese patients with acne vulgaris. Seven‐day repeated application of CLDM/BPO3% appears to be safe in this patient population. Concentrations of plasma and urine BA were below the limit of quantification before and after repeated application in most of the 12 adult male patients. Mean difference in Cmax and AUC0–last for plasma HA indicated increased exposures after repeated application, but with wide 90% confidence intervals. Mean Ae0–12 for urine HA was similar before and after repeated application. Repeated application of CLDM/BPO3% is thus unlikely to result in accumulation of BA and HA. The study suggests negligible systemic exposure to BPO metabolites from CLDM/BPO3% after 7‐day repeated application in male patients with acne vulgaris.</abstract><cop>United States</cop><pub>Blackwell Publishing Ltd</pub><pmid>27128000</pmid><doi>10.1002/cpdd.125</doi><tpages>7</tpages></addata></record> |
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| subjects | Acids Acne acne vulgaris Acne Vulgaris - blood Acne Vulgaris - diagnosis Acne Vulgaris - drug therapy Acne Vulgaris - ethnology Administration, Cutaneous Adult Anti-Bacterial Agents - administration & dosage Anti-Bacterial Agents - adverse effects Anti-Bacterial Agents - pharmacokinetics Area Under Curve Asian Continental Ancestry Group benzoic acid Benzoic Acid - blood Benzoic Acid - pharmacokinetics Benzoic Acid - urine benzoyl peroxide Benzoyl Peroxide - administration & dosage Benzoyl Peroxide - adverse effects Benzoyl Peroxide - pharmacokinetics Biotransformation Birth control Clindamycin - administration & dosage Clindamycin - adverse effects Clindamycin - pharmacokinetics Confidence intervals Dermatologic Agents - administration & dosage Dermatologic Agents - adverse effects Dermatologic Agents - pharmacokinetics Drug Administration Schedule Drug Combinations Drug Monitoring - methods Hippurates - blood Hippurates - pharmacokinetics Hippurates - urine hippuric acid Humans Japan Male Metabolic Clearance Rate pharmacokinetics Prescription drugs Urine Young Adult |
| title | Systemic exposure to benzoic acid and hippuric acid following topical application of clindamycin 1%/benzoyl peroxide 3% fixed-dose combination gel in Japanese patients with acne vulgaris |
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