Article(id=1292126431333610015, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126377440989952, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.01.017, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1760976000000, receivedDateStr=2025-10-21, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785996547778, onlineDateStr=2026-08-06, pubDate=1768579200000, pubDateStr=2026-01-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785996547778, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785996547778, creator=13701087609, updateTime=1785996547778, updator=13701087609, issue=Issue{id=1292126377440989952, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='1', pageStart='1', pageEnd='147', issueExtLink='null', onlineDate='null', pubDate='1768579200000', pubDateStr='2026-01-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785996534929, creator='13701087609', updateTime=1786014708731, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292202603945947673, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126377440989952, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292202603950141978, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126377440989952, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=107, endPage=111, ext={EN=ArticleExt(id=1292126431648182816, articleId=1292126431333610015, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Research on the effects of itraconazole on the pharmacokinetics of ADC189 and its metabolite ADC189-I07, columnId=1246531407389020354, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Pharmacokinetics and Bioequivalence Study, runingTitle=null, highlight=null, articleAbstract=
Objective To evaluate the effects of itraconazole capsules on the pharmacokinetics of a single oral dose of ADC189 and its metabolite ADC189-I07 in Chinese healthy subjects, and to assess the safety of their co-administration.
Methods This was a single-center, open-label, non-randomized, two-period, fixed-sequence trial, using itraconazole as an inhibitor of cytochrome P450 3A4 (CYP3A4), P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP). Analyze the impact of repeated administration of itraconazole capsules on the pharmacokinetic characteristics of ADC189 and its major metabolite ADC189-I07.
Results After co-administration of ADC189 with itraconazole, there was no difference in the maximum plasma concentration (Cmax) of the active metabolite ADC189-I07 in plasma compares with ADC189 alone; the geometric mean ratio was 106.64%, with a 90% confidence interval (CI) of 84.12%-135.16%. The area under the curve (AUC0-t) and AUC0-∞ increased by approximately 42.00% and 47.00%, respectively, with geometric mean ratios and 90% confidence intervals of 142.48% (120.84%-167.98%) and 147.25% (123.95%-174.91%), respectively. The 90% CIs for all three parameters did not fall entirely within the no-effect boundary of 80.00%-125.00%. The median time to peak drug concentration (tmax) of ADC189-I07 was 4.00 (3.00-4.00) after administration alone and 4.00 (3.00-12.00) h after co-administration; non-parametric tests showed no statistically significant difference in tmax (P>0.05). All adverse events (AEs) during the trial were grade 1 or 2, resolved spontaneously, and the safety risk was controllable.
Conclusion When ADC189 tablets are used clinically with a strong CYP3A4 inhibitor, no dosage adjustment is required for concomitant use.
, authors=Ning CHEN
1, 2, Jin-mei ZHOU
1, 2, Yu PENG
1, 2, Dao-lei ZHOU
1, 2, Xue-mei LOU
1, 2, Yu-jie LÜ
1, 2, Huan ZHOU
1, 2, authorsList=Ning CHEN, Jin-mei ZHOU, Yu PENG, Dao-lei ZHOU, Xue-mei LOU, Yu-jie LÜ, Huan ZHOU, authorCompany=null, correspAuthors=Huan ZHOU, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1292126433598534177, articleId=1292126431333610015, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=伊曲康唑对ADC189及其代谢产物ADC189-I07药代动力学影响的研究, columnId=1246531407988805834, journalTitle=中国临床药理学杂志, columnName=药代动力学与生物等效性研究, runingTitle=null, highlight=null, articleAbstract=
目的 评价伊曲康唑胶囊对中国健康受试者单次口服ADC189及代谢产物ADC189-I07药代动力学影响，并评估2药联用安全性。
方法 本研究选用单中心、开放、非随机、两周期、固定序列试验设计，伊曲康唑作为细胞色素P450 3A4酶（CYP3A4）、P-糖蛋白（P-gp）和乳腺癌耐药蛋白（BCRP）抑制剂，分析多次给予伊曲康唑胶囊对ADC189及其主要代谢产物ADC189-I07药代动力学特征影响。
结果 ADC189联合伊曲康唑给药后，与单独用药比较血浆中活性代谢产物ADC189-I07的达峰浓度（Cmax）在统计学上差异无统计学意义，几何均值比值为106.64%，90%置信区间为84.12%~135.16%；血药浓度-时间曲线下面积（AUC0-t）和AUC0-∞分别增加约42.00%和47.00%，几何均值比值及90%置信区间分别为142.48%（120.84%~167.98%）和147.25%（123.95%~174.91%），3者的90%CI未完全落在80.00%~125.00%无效应边界内。单独服用和联合给药后ADC189-I07的中位达峰时间（tmax）分别为4.00（3.00~4.00）和4.00（3.00~12.00）h，非参数检验显示，tmax在统计学上差异无统计学意义（P>0.05）。试验期间不良事件（AEs）均为1级或2级，可以自行恢复，安全风险可控。
结论 在临床使用ADC189片与CYP3A4强抑制剂时，合用时无需调整剂量。
, authors=陈宁
1, 2, 周锦梅
1, 2, 彭郁
1, 2, 周道磊
1, 2, 娄雪梅
1, 2, 吕玉洁
1, 2, 周焕
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陈宁（2000-），女，研究员，主要从事临床试验相关研究和工作
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