The effect of food on the pharmacokinetics of Sutetinib maleate capsule, an irreversible EGFR tyrosine kinase inhibitor, in healthy Chinese subjects
Sutetinib is an irreversible inhibitor of epidermal growth factor receptor (EGFR) and showed favorable efficacy and safety in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring nondrug-resistant rare EGFR mutations. To evaluate the potential food effect, eight...
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| creator | Cao, Bei Ma, Tingting Zhang, Yuqiang Huang, Lei Lin, Hui Jiang, Huanhuan Zhao, Yu Geng, Yan Yang, Yuanxun Cao, Sumin Li, Juan |
| description | Sutetinib is an irreversible inhibitor of epidermal growth factor receptor (EGFR) and showed favorable efficacy and safety in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring nondrug-resistant rare EGFR mutations. To evaluate the potential food effect, eighteen healthy Chinese subjects were enrolled in a single-centre, randomized, open-label, two-sequence, two-period crossover study. Sutetinib was administered as a single oral 100 mg under fasting or fed conditions, and pharmacokinetic sampling was performed following each dose and analysed by a validated liquid chromatography/mass spectrometry method. Safety and tolerability were also evaluated. Food intake slightly decreased maximum plasma concentration (C
max
) and area under the plasma concentration-time curve from time 0 to infinity (AUC
0 − inf
) of sutetinib (geometric least-squares mean [GLSM] ratio, 80.94% and 86.11%; 90% confidence interval [CI], 68.43–95.72 and 75.88–97.73) and its active metabolite sutetinib N-Oxide (GLSM ratio, 75.58% and 84.00%; 90% CI, 65.69–86.95 and 75.42–93.56), respectively. In addition, the time to maximum plasma concentration (T
max
) of both sutetinib and its metabolite has been prolonged by 2 h under fed conditions. A total of 31 adverse events (AEs) occurred during the study, with no serious adverse events (SAE) reported, and no obvious difference was observed between the fasting and fed groups. Our results demonstrated that a high-fat and high-calorie diet caused a significant delay in drug absorption and a marginal reduction in drug exposure. Sutetinib was generally well tolerated in healthy Chinese subjects. (This trial was registered at
http://www.chinadrugtrials.org.cn
.
The registration No. is CTR20201933, and the date of registration is 2020-10-16
).
Clinical trials registration number
CTR20201933 (
http://www.chinadrugtrials.org.cn/
) or ChiCTR2100045180 (
https://www.chictr.org.cn/
). |
| doi_str_mv | 10.1007/s10637-024-01436-0 |
| format | Article |
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max
) and area under the plasma concentration-time curve from time 0 to infinity (AUC
0 − inf
) of sutetinib (geometric least-squares mean [GLSM] ratio, 80.94% and 86.11%; 90% confidence interval [CI], 68.43–95.72 and 75.88–97.73) and its active metabolite sutetinib N-Oxide (GLSM ratio, 75.58% and 84.00%; 90% CI, 65.69–86.95 and 75.42–93.56), respectively. In addition, the time to maximum plasma concentration (T
max
) of both sutetinib and its metabolite has been prolonged by 2 h under fed conditions. A total of 31 adverse events (AEs) occurred during the study, with no serious adverse events (SAE) reported, and no obvious difference was observed between the fasting and fed groups. Our results demonstrated that a high-fat and high-calorie diet caused a significant delay in drug absorption and a marginal reduction in drug exposure. Sutetinib was generally well tolerated in healthy Chinese subjects. (This trial was registered at
http://www.chinadrugtrials.org.cn
.
The registration No. is CTR20201933, and the date of registration is 2020-10-16
).
Clinical trials registration number
CTR20201933 (
http://www.chinadrugtrials.org.cn/
) or ChiCTR2100045180 (
https://www.chictr.org.cn/
).</description><identifier>ISSN: 0167-6997</identifier><identifier>EISSN: 1573-0646</identifier><identifier>DOI: 10.1007/s10637-024-01436-0</identifier><identifier>PMID: 38602625</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Adult ; Adverse events ; Asian People ; Capsules ; Clinical trials ; Cross-Over Studies ; East Asian People ; Epidermal growth factor receptors ; ErbB Receptors - antagonists & inhibitors ; ErbB Receptors - genetics ; Fasting ; Female ; Food ; Food intake ; Food-Drug Interactions ; Growth factors ; Healthy Volunteers ; High fat diet ; Humans ; Kinases ; Liquid chromatography ; Lung cancer ; Male ; Mass spectrometry ; Mass spectroscopy ; Medicine ; Medicine & Public Health ; Metabolites ; Metastases ; Middle Aged ; Non-small cell lung carcinoma ; Oncology ; Pharmacokinetics ; Pharmacology/Toxicology ; Protein Kinase Inhibitors - administration & dosage ; Protein Kinase Inhibitors - adverse effects ; Protein Kinase Inhibitors - blood ; Protein Kinase Inhibitors - pharmacokinetics ; Registration ; Small cell lung carcinoma ; Tyrosine ; Tyrosine Kinase Inhibitors ; Young Adult</subject><ispartof>Investigational new drugs, 2024-06, Vol.42 (3), p.289-298</ispartof><rights>The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature 2024. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.</rights><rights>2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c326t-87b95cc3ebb51d5b8188dd0942aa941aa1205c82eb56ac15382a6898962c8c1d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s10637-024-01436-0$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10637-024-01436-0$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38602625$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Cao, Bei</creatorcontrib><creatorcontrib>Ma, Tingting</creatorcontrib><creatorcontrib>Zhang, Yuqiang</creatorcontrib><creatorcontrib>Huang, Lei</creatorcontrib><creatorcontrib>Lin, Hui</creatorcontrib><creatorcontrib>Jiang, Huanhuan</creatorcontrib><creatorcontrib>Zhao, Yu</creatorcontrib><creatorcontrib>Geng, Yan</creatorcontrib><creatorcontrib>Yang, Yuanxun</creatorcontrib><creatorcontrib>Cao, Sumin</creatorcontrib><creatorcontrib>Li, Juan</creatorcontrib><title>The effect of food on the pharmacokinetics of Sutetinib maleate capsule, an irreversible EGFR tyrosine kinase inhibitor, in healthy Chinese subjects</title><title>Investigational new drugs</title><addtitle>Invest New Drugs</addtitle><addtitle>Invest New Drugs</addtitle><description>Sutetinib is an irreversible inhibitor of epidermal growth factor receptor (EGFR) and showed favorable efficacy and safety in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring nondrug-resistant rare EGFR mutations. To evaluate the potential food effect, eighteen healthy Chinese subjects were enrolled in a single-centre, randomized, open-label, two-sequence, two-period crossover study. Sutetinib was administered as a single oral 100 mg under fasting or fed conditions, and pharmacokinetic sampling was performed following each dose and analysed by a validated liquid chromatography/mass spectrometry method. Safety and tolerability were also evaluated. Food intake slightly decreased maximum plasma concentration (C
max
) and area under the plasma concentration-time curve from time 0 to infinity (AUC
0 − inf
) of sutetinib (geometric least-squares mean [GLSM] ratio, 80.94% and 86.11%; 90% confidence interval [CI], 68.43–95.72 and 75.88–97.73) and its active metabolite sutetinib N-Oxide (GLSM ratio, 75.58% and 84.00%; 90% CI, 65.69–86.95 and 75.42–93.56), respectively. In addition, the time to maximum plasma concentration (T
max
) of both sutetinib and its metabolite has been prolonged by 2 h under fed conditions. A total of 31 adverse events (AEs) occurred during the study, with no serious adverse events (SAE) reported, and no obvious difference was observed between the fasting and fed groups. Our results demonstrated that a high-fat and high-calorie diet caused a significant delay in drug absorption and a marginal reduction in drug exposure. Sutetinib was generally well tolerated in healthy Chinese subjects. (This trial was registered at
http://www.chinadrugtrials.org.cn
.
The registration No. is CTR20201933, and the date of registration is 2020-10-16
).
Clinical trials registration number
CTR20201933 (
http://www.chinadrugtrials.org.cn/
) or ChiCTR2100045180 (
https://www.chictr.org.cn/
).</description><subject>Adult</subject><subject>Adverse events</subject><subject>Asian People</subject><subject>Capsules</subject><subject>Clinical trials</subject><subject>Cross-Over Studies</subject><subject>East Asian People</subject><subject>Epidermal growth factor receptors</subject><subject>ErbB Receptors - antagonists & inhibitors</subject><subject>ErbB Receptors - genetics</subject><subject>Fasting</subject><subject>Female</subject><subject>Food</subject><subject>Food intake</subject><subject>Food-Drug Interactions</subject><subject>Growth factors</subject><subject>Healthy Volunteers</subject><subject>High fat diet</subject><subject>Humans</subject><subject>Kinases</subject><subject>Liquid chromatography</subject><subject>Lung cancer</subject><subject>Male</subject><subject>Mass spectrometry</subject><subject>Mass spectroscopy</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Metabolites</subject><subject>Metastases</subject><subject>Middle Aged</subject><subject>Non-small cell lung carcinoma</subject><subject>Oncology</subject><subject>Pharmacokinetics</subject><subject>Pharmacology/Toxicology</subject><subject>Protein Kinase Inhibitors - administration & dosage</subject><subject>Protein Kinase Inhibitors - adverse effects</subject><subject>Protein Kinase Inhibitors - blood</subject><subject>Protein Kinase Inhibitors - pharmacokinetics</subject><subject>Registration</subject><subject>Small cell lung carcinoma</subject><subject>Tyrosine</subject><subject>Tyrosine Kinase Inhibitors</subject><subject>Young Adult</subject><issn>0167-6997</issn><issn>1573-0646</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kc2OFCEUhYnROG3rC7gwJG5cTCk_BQVL05kZTSYx0XFNgLpl0VYVLVAm_R4-sLQ9auLCFTec7xwuOQg9p-Q1JaR7kymRvGsIaxtCWy4b8gBtqOh4Q2QrH6INobJrpNbdBXqS854QwnXXPkYXXEnCJBMb9ONuBAzDAL7gOOAhxh7HBZd6exhtmq2PX8MCJfh80j-tpc5LcHi2E9gC2NtDXie4xHbBISX4DikHNwG-urn-iMsxxVz9uIbYDDgsY3ChxHRZRzyCncp4xLuxIlXNq9vXRfJT9GiwU4Zn9-cWfb6-utu9a24_3Lzfvb1tPGeyNKpzWnjPwTlBe-EUVarviW6Ztbql1lJGhFcMnJDWU8EVs1JppSXzytOeb9Grc-4hxW8r5GLmkD1Mk10grtlwwjuuBdW6oi__QfdxTUvdrlJSUq5IpbeInSlfv50TDOaQwmzT0VBiTp2Zc2emdmZ-dWZOphf30aubof9j-V1SBfgZyFVavkD6-_Z_Yn8Ca5ii1Q</recordid><startdate>20240601</startdate><enddate>20240601</enddate><creator>Cao, Bei</creator><creator>Ma, Tingting</creator><creator>Zhang, Yuqiang</creator><creator>Huang, Lei</creator><creator>Lin, Hui</creator><creator>Jiang, Huanhuan</creator><creator>Zhao, Yu</creator><creator>Geng, Yan</creator><creator>Yang, Yuanxun</creator><creator>Cao, Sumin</creator><creator>Li, Juan</creator><general>Springer US</general><general>Springer Nature B.V</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>7QO</scope><scope>8FD</scope><scope>FR3</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>P64</scope><scope>7X8</scope></search><sort><creationdate>20240601</creationdate><title>The effect of food on the pharmacokinetics of Sutetinib maleate capsule, an irreversible EGFR tyrosine kinase inhibitor, in healthy Chinese subjects</title><author>Cao, Bei ; Ma, Tingting ; Zhang, Yuqiang ; Huang, Lei ; Lin, Hui ; Jiang, Huanhuan ; Zhao, Yu ; Geng, Yan ; Yang, Yuanxun ; Cao, Sumin ; Li, Juan</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c326t-87b95cc3ebb51d5b8188dd0942aa941aa1205c82eb56ac15382a6898962c8c1d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Adult</topic><topic>Adverse events</topic><topic>Asian People</topic><topic>Capsules</topic><topic>Clinical trials</topic><topic>Cross-Over Studies</topic><topic>East Asian People</topic><topic>Epidermal growth factor receptors</topic><topic>ErbB Receptors - antagonists & inhibitors</topic><topic>ErbB Receptors - genetics</topic><topic>Fasting</topic><topic>Female</topic><topic>Food</topic><topic>Food intake</topic><topic>Food-Drug Interactions</topic><topic>Growth factors</topic><topic>Healthy Volunteers</topic><topic>High fat diet</topic><topic>Humans</topic><topic>Kinases</topic><topic>Liquid chromatography</topic><topic>Lung cancer</topic><topic>Male</topic><topic>Mass spectrometry</topic><topic>Mass spectroscopy</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Metabolites</topic><topic>Metastases</topic><topic>Middle Aged</topic><topic>Non-small cell lung carcinoma</topic><topic>Oncology</topic><topic>Pharmacokinetics</topic><topic>Pharmacology/Toxicology</topic><topic>Protein Kinase Inhibitors - administration & dosage</topic><topic>Protein Kinase Inhibitors - adverse effects</topic><topic>Protein Kinase Inhibitors - blood</topic><topic>Protein Kinase Inhibitors - pharmacokinetics</topic><topic>Registration</topic><topic>Small cell lung carcinoma</topic><topic>Tyrosine</topic><topic>Tyrosine Kinase Inhibitors</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Cao, Bei</creatorcontrib><creatorcontrib>Ma, Tingting</creatorcontrib><creatorcontrib>Zhang, Yuqiang</creatorcontrib><creatorcontrib>Huang, Lei</creatorcontrib><creatorcontrib>Lin, Hui</creatorcontrib><creatorcontrib>Jiang, Huanhuan</creatorcontrib><creatorcontrib>Zhao, Yu</creatorcontrib><creatorcontrib>Geng, Yan</creatorcontrib><creatorcontrib>Yang, Yuanxun</creatorcontrib><creatorcontrib>Cao, Sumin</creatorcontrib><creatorcontrib>Li, Juan</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Biotechnology Research Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Investigational new drugs</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Cao, Bei</au><au>Ma, Tingting</au><au>Zhang, Yuqiang</au><au>Huang, Lei</au><au>Lin, Hui</au><au>Jiang, Huanhuan</au><au>Zhao, Yu</au><au>Geng, Yan</au><au>Yang, Yuanxun</au><au>Cao, Sumin</au><au>Li, Juan</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The effect of food on the pharmacokinetics of Sutetinib maleate capsule, an irreversible EGFR tyrosine kinase inhibitor, in healthy Chinese subjects</atitle><jtitle>Investigational new drugs</jtitle><stitle>Invest New Drugs</stitle><addtitle>Invest New Drugs</addtitle><date>2024-06-01</date><risdate>2024</risdate><volume>42</volume><issue>3</issue><spage>289</spage><epage>298</epage><pages>289-298</pages><issn>0167-6997</issn><eissn>1573-0646</eissn><abstract>Sutetinib is an irreversible inhibitor of epidermal growth factor receptor (EGFR) and showed favorable efficacy and safety in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring nondrug-resistant rare EGFR mutations. To evaluate the potential food effect, eighteen healthy Chinese subjects were enrolled in a single-centre, randomized, open-label, two-sequence, two-period crossover study. Sutetinib was administered as a single oral 100 mg under fasting or fed conditions, and pharmacokinetic sampling was performed following each dose and analysed by a validated liquid chromatography/mass spectrometry method. Safety and tolerability were also evaluated. Food intake slightly decreased maximum plasma concentration (C
max
) and area under the plasma concentration-time curve from time 0 to infinity (AUC
0 − inf
) of sutetinib (geometric least-squares mean [GLSM] ratio, 80.94% and 86.11%; 90% confidence interval [CI], 68.43–95.72 and 75.88–97.73) and its active metabolite sutetinib N-Oxide (GLSM ratio, 75.58% and 84.00%; 90% CI, 65.69–86.95 and 75.42–93.56), respectively. In addition, the time to maximum plasma concentration (T
max
) of both sutetinib and its metabolite has been prolonged by 2 h under fed conditions. A total of 31 adverse events (AEs) occurred during the study, with no serious adverse events (SAE) reported, and no obvious difference was observed between the fasting and fed groups. Our results demonstrated that a high-fat and high-calorie diet caused a significant delay in drug absorption and a marginal reduction in drug exposure. Sutetinib was generally well tolerated in healthy Chinese subjects. (This trial was registered at
http://www.chinadrugtrials.org.cn
.
The registration No. is CTR20201933, and the date of registration is 2020-10-16
).
Clinical trials registration number
CTR20201933 (
http://www.chinadrugtrials.org.cn/
) or ChiCTR2100045180 (
https://www.chictr.org.cn/
).</abstract><cop>New York</cop><pub>Springer US</pub><pmid>38602625</pmid><doi>10.1007/s10637-024-01436-0</doi><tpages>10</tpages></addata></record> |
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| subjects | Adult Adverse events Asian People Capsules Clinical trials Cross-Over Studies East Asian People Epidermal growth factor receptors ErbB Receptors - antagonists & inhibitors ErbB Receptors - genetics Fasting Female Food Food intake Food-Drug Interactions Growth factors Healthy Volunteers High fat diet Humans Kinases Liquid chromatography Lung cancer Male Mass spectrometry Mass spectroscopy Medicine Medicine & Public Health Metabolites Metastases Middle Aged Non-small cell lung carcinoma Oncology Pharmacokinetics Pharmacology/Toxicology Protein Kinase Inhibitors - administration & dosage Protein Kinase Inhibitors - adverse effects Protein Kinase Inhibitors - blood Protein Kinase Inhibitors - pharmacokinetics Registration Small cell lung carcinoma Tyrosine Tyrosine Kinase Inhibitors Young Adult |
| title | The effect of food on the pharmacokinetics of Sutetinib maleate capsule, an irreversible EGFR tyrosine kinase inhibitor, in healthy Chinese subjects |
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