A Randomized, Open-Label, Bioequivalence Study of Lidocaine Topical System 1.8% and Lidocaine Patch 5% in Healthy Subjects.
Identifieur interne : 000120 ( Main/Corpus ); précédent : 000119; suivant : 000121A Randomized, Open-Label, Bioequivalence Study of Lidocaine Topical System 1.8% and Lidocaine Patch 5% in Healthy Subjects.
Auteurs : Jeffrey Gudin ; Charles Argoff ; Jeffrey Fudin ; Emileigh Greuber ; Kip Vought ; Kalpana Patel ; Sri NalamachuSource :
- Journal of pain research [ 1178-7090 ] ; 2020.
Abstract
Purpose
This study was designed to characterize drug delivery with lidocaine topical system 1.8% vs lidocaine patch 5% through 2 PK studies.
Patients and Methods
Two Phase 1, single-center, open-label, randomized PK studies were performed in healthy adults. In Study 1, 56 subjects received a single intravenous bolus of 0.7 mg/kg of lidocaine as a lead-in to allow for the accurate determination of apparent dose of both products. After a 7-day washout period, subjects were randomized to receive either lidocaine topical system 1.8% or lidocaine patch 5% for 12 hours followed by another 7-day washout period, after which subjects crossed over to receive the other treatment for 12 hours. In Study 2, 54 subjects were randomized to receive either lidocaine topical system 1.8% or lidocaine patch 5% for 12 hours. After a 7-day washout period, subjects crossed over to receive the other treatment. Adhesion and skin irritation assessments were performed after application of the products in Study 2. In both studies, serial blood samples were collected to measure the plasma concentration of lidocaine after product application. Safety assessments and adverse events were monitored in both studies.
Results
The comparative PK analysis demonstrated that the two products, despite their difference in drug load and strength, are bioequivalent. Both products were well tolerated. In Study 2, dermal response scores (skin tolerability after removal) were similar between lidocaine topical system 1.8% and lidocaine patch 5%, with a mean irritation score per patch <1 (barely perceptible erythema), which is not considered to be clinically significant.
Conclusion
Bioequivalence was demonstrated between lidocaine topical system 1.8% and lidocaine patch 5%. A comparison of the single-time adhesion scores at 12 hours in Study 2 favored lidocaine topical system 1.8% over lidocaine patch 5%. Both products were well tolerated as a single application in healthy adult human subjects.
ClinicalTrialsgov
NCT04144192, NCT04149938.
DOI: 10.2147/JPR.S237934
PubMed: 32606914
PubMed Central: PMC7319520
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pubmed:32606914Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">A Randomized, Open-Label, Bioequivalence Study of Lidocaine Topical System 1.8% and Lidocaine Patch 5% in Healthy Subjects.</title><author><name sortKey="Gudin, Jeffrey" sort="Gudin, Jeffrey" uniqKey="Gudin J" first="Jeffrey" last="Gudin">Jeffrey Gudin</name><affiliation><nlm:affiliation>Department of Anesthesiology, Englewood Hospital and Medical Center, Englewood, NJ, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Argoff, Charles" sort="Argoff, Charles" uniqKey="Argoff C" first="Charles" last="Argoff">Charles Argoff</name><affiliation><nlm:affiliation>Department of Neurology, Albany Medical Center, Albany, NY, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Fudin, Jeffrey" sort="Fudin, Jeffrey" uniqKey="Fudin J" first="Jeffrey" last="Fudin">Jeffrey Fudin</name><affiliation><nlm:affiliation>Professional Practice, Albany College of Pharmacy and Health Sciences, Albany, NY, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Greuber, Emileigh" sort="Greuber, Emileigh" uniqKey="Greuber E" first="Emileigh" last="Greuber">Emileigh Greuber</name><affiliation><nlm:affiliation>Scilex Pharmaceuticals Inc., Palo Alto, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Vought, Kip" sort="Vought, Kip" uniqKey="Vought K" first="Kip" last="Vought">Kip Vought</name><affiliation><nlm:affiliation>Scilex Pharmaceuticals Inc., Palo Alto, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Patel, Kalpana" sort="Patel, Kalpana" uniqKey="Patel K" first="Kalpana" last="Patel">Kalpana Patel</name><affiliation><nlm:affiliation>Scilex Pharmaceuticals Inc., Palo Alto, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Nalamachu, Sri" sort="Nalamachu, Sri" uniqKey="Nalamachu S" first="Sri" last="Nalamachu">Sri Nalamachu</name><affiliation><nlm:affiliation>Mid America PolyClinic, Overland Park, KS, USA.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2020">2020</date><idno type="RBID">pubmed:32606914</idno><idno type="pmid">32606914</idno><idno type="doi">10.2147/JPR.S237934</idno><idno type="pmc">PMC7319520</idno><idno type="wicri:Area/Main/Corpus">000120</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000120</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">A Randomized, Open-Label, Bioequivalence Study of Lidocaine Topical System 1.8% and Lidocaine Patch 5% in Healthy Subjects.</title><author><name sortKey="Gudin, Jeffrey" sort="Gudin, Jeffrey" uniqKey="Gudin J" first="Jeffrey" last="Gudin">Jeffrey Gudin</name><affiliation><nlm:affiliation>Department of Anesthesiology, Englewood Hospital and Medical Center, Englewood, NJ, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Argoff, Charles" sort="Argoff, Charles" uniqKey="Argoff C" first="Charles" last="Argoff">Charles Argoff</name><affiliation><nlm:affiliation>Department of Neurology, Albany Medical Center, Albany, NY, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Fudin, Jeffrey" sort="Fudin, Jeffrey" uniqKey="Fudin J" first="Jeffrey" last="Fudin">Jeffrey Fudin</name><affiliation><nlm:affiliation>Professional Practice, Albany College of Pharmacy and Health Sciences, Albany, NY, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Greuber, Emileigh" sort="Greuber, Emileigh" uniqKey="Greuber E" first="Emileigh" last="Greuber">Emileigh Greuber</name><affiliation><nlm:affiliation>Scilex Pharmaceuticals Inc., Palo Alto, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Vought, Kip" sort="Vought, Kip" uniqKey="Vought K" first="Kip" last="Vought">Kip Vought</name><affiliation><nlm:affiliation>Scilex Pharmaceuticals Inc., Palo Alto, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Patel, Kalpana" sort="Patel, Kalpana" uniqKey="Patel K" first="Kalpana" last="Patel">Kalpana Patel</name><affiliation><nlm:affiliation>Scilex Pharmaceuticals Inc., Palo Alto, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Nalamachu, Sri" sort="Nalamachu, Sri" uniqKey="Nalamachu S" first="Sri" last="Nalamachu">Sri Nalamachu</name><affiliation><nlm:affiliation>Mid America PolyClinic, Overland Park, KS, USA.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Journal of pain research</title><idno type="ISSN">1178-7090</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>Purpose</b></p><p>This study was designed to characterize drug delivery with lidocaine topical system 1.8% vs lidocaine patch 5% through 2 PK studies.</p></div><div type="abstract" xml:lang="en"><p><b>Patients and Methods</b></p><p>Two Phase 1, single-center, open-label, randomized PK studies were performed in healthy adults. In Study 1, 56 subjects received a single intravenous bolus of 0.7 mg/kg of lidocaine as a lead-in to allow for the accurate determination of apparent dose of both products. After a 7-day washout period, subjects were randomized to receive either lidocaine topical system 1.8% or lidocaine patch 5% for 12 hours followed by another 7-day washout period, after which subjects crossed over to receive the other treatment for 12 hours. In Study 2, 54 subjects were randomized to receive either lidocaine topical system 1.8% or lidocaine patch 5% for 12 hours. After a 7-day washout period, subjects crossed over to receive the other treatment. Adhesion and skin irritation assessments were performed after application of the products in Study 2. In both studies, serial blood samples were collected to measure the plasma concentration of lidocaine after product application. Safety assessments and adverse events were monitored in both studies.</p></div><div type="abstract" xml:lang="en"><p><b>Results</b></p><p>The comparative PK analysis demonstrated that the two products, despite their difference in drug load and strength, are bioequivalent. Both products were well tolerated. In Study 2, dermal response scores (skin tolerability after removal) were similar between lidocaine topical system 1.8% and lidocaine patch 5%, with a mean irritation score per patch <1 (barely perceptible erythema), which is not considered to be clinically significant.</p></div><div type="abstract" xml:lang="en"><p><b>Conclusion</b></p><p>Bioequivalence was demonstrated between lidocaine topical system 1.8% and lidocaine patch 5%. A comparison of the single-time adhesion scores at 12 hours in Study 2 favored lidocaine topical system 1.8% over lidocaine patch 5%. Both products were well tolerated as a single application in healthy adult human subjects.</p></div><div type="abstract" xml:lang="en"><p><b>ClinicalTrialsgov</b></p><p>NCT04144192, NCT04149938.</p></div></front></TEI><pubmed><MedlineCitation Status="PubMed-not-MEDLINE" Owner="NLM"><PMID Version="1">32606914</PMID><DateRevised><Year>2020</Year><Month>09</Month><Day>28</Day></DateRevised><Article PubModel="Electronic-eCollection"><Journal><ISSN IssnType="Print">1178-7090</ISSN><JournalIssue CitedMedium="Print"><Volume>13</Volume><PubDate><Year>2020</Year></PubDate></JournalIssue><Title>Journal of pain research</Title><ISOAbbreviation>J Pain Res</ISOAbbreviation></Journal><ArticleTitle>A Randomized, Open-Label, Bioequivalence Study of Lidocaine Topical System 1.8% and Lidocaine Patch 5% in Healthy Subjects.</ArticleTitle><Pagination><MedlinePgn>1485-1496</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.2147/JPR.S237934</ELocationID><Abstract><AbstractText Label="Purpose" NlmCategory="UNASSIGNED">This study was designed to characterize drug delivery with lidocaine topical system 1.8% vs lidocaine patch 5% through 2 PK studies.</AbstractText><AbstractText Label="Patients and Methods" NlmCategory="UNASSIGNED">Two Phase 1, single-center, open-label, randomized PK studies were performed in healthy adults. In Study 1, 56 subjects received a single intravenous bolus of 0.7 mg/kg of lidocaine as a lead-in to allow for the accurate determination of apparent dose of both products. After a 7-day washout period, subjects were randomized to receive either lidocaine topical system 1.8% or lidocaine patch 5% for 12 hours followed by another 7-day washout period, after which subjects crossed over to receive the other treatment for 12 hours. In Study 2, 54 subjects were randomized to receive either lidocaine topical system 1.8% or lidocaine patch 5% for 12 hours. After a 7-day washout period, subjects crossed over to receive the other treatment. Adhesion and skin irritation assessments were performed after application of the products in Study 2. In both studies, serial blood samples were collected to measure the plasma concentration of lidocaine after product application. Safety assessments and adverse events were monitored in both studies.</AbstractText><AbstractText Label="Results" NlmCategory="UNASSIGNED">The comparative PK analysis demonstrated that the two products, despite their difference in drug load and strength, are bioequivalent. Both products were well tolerated. In Study 2, dermal response scores (skin tolerability after removal) were similar between lidocaine topical system 1.8% and lidocaine patch 5%, with a mean irritation score per patch <1 (barely perceptible erythema), which is not considered to be clinically significant.</AbstractText><AbstractText Label="Conclusion" NlmCategory="UNASSIGNED">Bioequivalence was demonstrated between lidocaine topical system 1.8% and lidocaine patch 5%. A comparison of the single-time adhesion scores at 12 hours in Study 2 favored lidocaine topical system 1.8% over lidocaine patch 5%. Both products were well tolerated as a single application in healthy adult human subjects.</AbstractText><AbstractText Label="ClinicalTrialsgov" NlmCategory="UNASSIGNED">NCT04144192, NCT04149938.</AbstractText><CopyrightInformation>© 2020 Gudin et al.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Gudin</LastName><ForeName>Jeffrey</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Anesthesiology, Englewood Hospital and Medical Center, Englewood, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Argoff</LastName><ForeName>Charles</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Department of Neurology, Albany Medical Center, Albany, NY, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fudin</LastName><ForeName>Jeffrey</ForeName><Initials>J</Initials><Identifier Source="ORCID">0000-0001-9929-1909</Identifier><AffiliationInfo><Affiliation>Professional Practice, Albany College of Pharmacy and Health Sciences, Albany, NY, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Greuber</LastName><ForeName>Emileigh</ForeName><Initials>E</Initials><Identifier Source="ORCID">0000-0001-6450-1988</Identifier><AffiliationInfo><Affiliation>Scilex Pharmaceuticals Inc., Palo Alto, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Vought</LastName><ForeName>Kip</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Scilex Pharmaceuticals Inc., Palo Alto, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Patel</LastName><ForeName>Kalpana</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Scilex Pharmaceuticals Inc., Palo Alto, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nalamachu</LastName><ForeName>Sri</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Mid America PolyClinic, Overland Park, KS, USA.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT04144192</AccessionNumber><AccessionNumber>NCT04149938</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>06</Month><Day>22</Day></ArticleDate></Article><MedlineJournalInfo><Country>New Zealand</Country><MedlineTA>J Pain Res</MedlineTA><NlmUniqueID>101540514</NlmUniqueID><ISSNLinking>1178-7090</ISSNLinking></MedlineJournalInfo><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">lidocaine</Keyword><Keyword MajorTopicYN="N">pharmacokinetics</Keyword><Keyword MajorTopicYN="N">postherpetic neuralgia</Keyword><Keyword MajorTopicYN="N">topical</Keyword></KeywordList><CoiStatement>The abstract of this paper was presented at the PAINWeek 2018 Conference (September 4–8, 2018; Las Vegas, NV) as a poster presentation with interim findings. The poster’s abstract was published in “Poster Abstracts” in 2018 Postgraduate Medicine: Patel K, Gudin J, Vought K, Shah M, Grimes D, LaStella P, Greuber E. A Randomized, Comparative Pharmacokinetic (PK) Study of ZTlido™ Lidocaine Topical System 1.8% (36 mg) Versus Lidoderm® Lidocaine Patch 5% (700 mg). (2018) PAINWeek Abstract Book 2018, Postgrad Med, 130:sup1, 1–91, DOI: 10.1080/00325481.2018.1512253. In the past year, Dr. Gudin has been an advisor, consultant, or speaker’s bureau member for Averitas Pharma, BioDelivery Sciences International, Inc., Daiichi Sankyo, Hisamitsu Pharmaceutical Co. Inc., Nektar Therapeutics, Salix Pharmaceuticals, and Scilex Pharmaceuticals Inc. Dr. Fudin has been an advisor, consultant, or speaker’s bureau member for Abbott Laboratories, AcelRx Pharmaceuticals, Acutis Diagnostics Inc., AstraZeneca, BioDelivery Sciences International, Inc., Daiichi Sankyo, Firstox Laboratories, GlaxoSmithKline, Human Half-Cell, Inc., Quest Diagnostics, Salix Pharmaceuticals, and Scilex Pharmaceuticals Inc. Dr. Nalamachu has been a consultant/speaker and has received honorarium and grants from Allergan, AstraZeneca, BioDelivery Sciences International, Inc., Collegium Pharmaceuticals, Daiichi Sankyo, Depomed (Assertio Therapeutics), Eli Lilly and Company, Endo Pharmaceuticals, Ferring Pharmaceuticals, Insys Pharmaceuticals, Pernix Therapeutics, Pfizer Inc., Purdue Pharmaceuticals, and Scilex Pharmaceuticals Inc. Drs. Vought and Greuber have patent application 62/762753 pending to Scilex Pharmaceuticals Inc., and Dr Vought is head of R&D responsible for the design and conduct of the study. Drs. Greuber, Patel, and Vought are employees of Scilex Pharmaceuticals Inc., and they report grants and personal fees from Scilex Pharmaceuticals Inc. The authors report no other conflicts of interest in this work.</CoiStatement></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2019</Year><Month>11</Month><Day>09</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2020</Year><Month>03</Month><Day>07</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>7</Month><Day>2</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2020</Year><Month>7</Month><Day>2</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2020</Year><Month>7</Month><Day>2</Day><Hour>6</Hour><Minute>1</Minute></PubMedPubDate></History><PublicationStatus>epublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">32606914</ArticleId><ArticleId IdType="doi">10.2147/JPR.S237934</ArticleId><ArticleId IdType="pii">237934</ArticleId><ArticleId IdType="pmc">PMC7319520</ArticleId></ArticleIdList><ReferenceList><Reference><Citation>J Pain Palliat Care Pharmacother. 2015 Jun;29(2):180-1</Citation><ArticleIdList><ArticleId IdType="pubmed">26095493</ArticleId></ArticleIdList></Reference><Reference><Citation>Eur J Pharm Biopharm. 2006 Aug;64(1):1-8</Citation><ArticleIdList><ArticleId IdType="pubmed">16797171</ArticleId></ArticleIdList></Reference><Reference><Citation>Pain. 1996 Apr;65(1):39-44</Citation><ArticleIdList><ArticleId IdType="pubmed">8826488</ArticleId></ArticleIdList></Reference><Reference><Citation>J Pain Res. 2014 Mar 10;7:125-32</Citation><ArticleIdList><ArticleId IdType="pubmed">24648752</ArticleId></ArticleIdList></Reference><Reference><Citation>J Oral Maxillofac Pathol. 2016 Sep-Dec;20(3):547</Citation><ArticleIdList><ArticleId IdType="pubmed">27721631</ArticleId></ArticleIdList></Reference><Reference><Citation>Postgrad Med. 2020 Jan;132(1):28-36</Citation><ArticleIdList><ArticleId IdType="pubmed">31900074</ArticleId></ArticleIdList></Reference><Reference><Citation>Postgrad Med. 2013 Jul;125(4 Suppl 1):25-33</Citation><ArticleIdList><ArticleId IdType="pubmed">24547601</ArticleId></ArticleIdList></Reference><Reference><Citation>Curr Med Res Opin. 2009 May;25(5):1295-305</Citation><ArticleIdList><ArticleId IdType="pubmed">19366301</ArticleId></ArticleIdList></Reference><Reference><Citation>BMJ. 2019 Jan 10;364:k5095</Citation><ArticleIdList><ArticleId IdType="pubmed">30630827</ArticleId></ArticleIdList></Reference><Reference><Citation>Curr Med Res Opin. 2012 Aug;28(8):1337-46</Citation><ArticleIdList><ArticleId IdType="pubmed">22769236</ArticleId></ArticleIdList></Reference><Reference><Citation>AAPS PharmSciTech. 2016 Jun;17(3):588-96</Citation><ArticleIdList><ArticleId IdType="pubmed">26283198</ArticleId></ArticleIdList></Reference><Reference><Citation>Pain. 1999 Apr;80(3):533-8</Citation><ArticleIdList><ArticleId IdType="pubmed">10342414</ArticleId></ArticleIdList></Reference><Reference><Citation>N Engl J Med. 2013 Jul 18;369(3):255-63</Citation><ArticleIdList><ArticleId IdType="pubmed">23863052</ArticleId></ArticleIdList></Reference><Reference><Citation>N Engl J Med. 2014 Oct 16;371(16):1526-33</Citation><ArticleIdList><ArticleId IdType="pubmed">25317872</ArticleId></ArticleIdList></Reference><Reference><Citation>Curr Pain Headache Rep. 2016 Mar;20(3):17</Citation><ArticleIdList><ArticleId IdType="pubmed">26879875</ArticleId></ArticleIdList></Reference></ReferenceList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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