[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655200":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":11,"studyPopulation":11,"armGroups":23,"interventions":35,"overallOfficials":11,"centralContacts":11,"locations":43,"responsibleParty":64,"collaborators":11,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":11,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":11,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":11,"overallStatus":46,"whyStopped":11,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Betta Pharmaceuticals Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9,13,15],{"measure":10,"description":11,"timeFrame":12},"Maximum plasma concentration (Cmax)",null,"From pre-dose to 312 hours post-dose in rifampicin group. From pre-dose to 384 hours post-dose in itraconazole group.",{"measure":14,"description":11,"timeFrame":12},"Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC₀-t)",{"measure":16,"description":11,"timeFrame":12},"Area under the plasma concentration-time curve from time 0 to infinity (AUC₀-∞)",{"allocation":18,"interventionModel":19,"interventionModelDescription":11,"primaryPurpose":20,"observationalModel":11,"timePerspective":11,"maskingInfo":21},"NON_RANDOMIZED","CROSSOVER","OTHER",{"masking":22,"maskingDescription":11,"whoMasked":11},"NONE",[24,30],{"label":25,"type":26,"description":27,"interventionNames":28},"The rifampicin group","EXPERIMENTAL","Participants will receive a single oral dose of Befotertinib capsules on the morning of Day 1, and continuous oral administration of rifampicin every morning from Day 19 to Day 27 and Day29 to Day 40. On the morning of Day 28, participants will take Befotertinib capsules and rifampicin.",[29],"Drug: Befotertinib and rifampicin",{"label":31,"type":26,"description":32,"interventionNames":33},"The itraconazole group","Participants will receive a single oral dose of Befotertinib capsules on the morning of Day 1, and continuous oral administration of itraconazole every morning from Day 19 to Day 21 and Day 23 to Day 32. On the morning of Day 22 participants will take Befotertinib capsulets and itraconazole.",[34],"Drug: Befotertinib and itraconazole",[36,40],{"type":37,"name":38,"description":27,"armGroupLabels":39,"otherNames":11},"DRUG","Befotertinib and rifampicin",[25],{"type":37,"name":41,"description":32,"armGroupLabels":42,"otherNames":11},"Befotertinib and itraconazole",[31],[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"The Second Affiliated Hospital Zhejiang University School of Medicine","RECRUITING","Hangzhou","Zhejiang","310052","China","CN",{"type":53,"coordinates":54},"Point",[55,56],120.16142,30.29365,{"lat":56,"lon":55},[59],{"name":60,"role":61,"phone":62,"phoneExt":11,"email":63},"Bo Jiang","CONTACT","86-0571-87315215","jiangbo@zju.ed",{"type":65,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100655200","phase-1-drug-drug-interaction-study-of-befotertinib-capsules-in-healthy-participants-100655200",false,"NCT07809815","Drug-Drug Interaction Study of Befotertinib Capsules in Healthy Participants.","A Single-Center, Open-Label, Same-Subject Sequential Crossover Clinical Trial to Evaluate the Effects of Rifampicin or Itraconazole on the Pharmacokinetics of Befotertinib Capsules in Healthy Participants","Inclusion Criteria:\n\n* 1\\. Body weight: ≥45 kg for females and ≥50 kg for males; body mass index (BMI) at screening ranging from 19 to 26 kg\u002Fm² (inclusive) \\[BMI = weight (kg)\u002Fheight² (m²)\\];\n* 2\\. Results of examinations at screening and baseline (including physical examination, vital signs, laboratory tests: complete blood count, blood biochemistry, coagulation function, urinalysis, electrocardiogram, chest X-ray, etc.) are within normal limits, or abnormalities are present but judged by the investigator to have no clinical significance.\n\nExclusion Criteria:\n\n* 1\\. History of chronic systemic or severe diseases involving the cardiovascular, hepatic, renal, pulmonary, gastrointestinal, neurological, musculoskeletal, hematopoietic or metabolic systems, particularly surgical conditions or illnesses that may affect drug absorption, distribution, metabolism and excretion;\n* 2\\. A personal or family history of long QT syndrome, or QTcF interval \\>450 ms in males and \\>470 ms in females; clinically significant ventricular arrhythmias and conduction blocks;\n* 3\\. Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health supplements within 14 days prior to screening;\n* 4\\. Special dietary requirements (habitual consumption of grapefruit juice or excessive tea, coffee and\u002For caffeine-containing beverages) and inability to abstain during the trial; inability to accept standardized meals during hospitalization;\n* 5\\. Weekly alcohol intake of ≥14 alcohol units within 3 months before screening or positive breath alcohol test prior to enrolment; participants who cannot refrain from alcohol consumption throughout the study from signing the informed consent form until study completion.",true,"ALL","18 Years","45 Years",{"count":78,"type":79},36,"ESTIMATED","INTERVENTIONAL",[82],"PHASE1","This study adopts a single-center, open-label, same-subject sequential crossover clinical trial design, aiming to evaluate the effects of oral administration of rifampicin or itraconazole on the pharmacokinetic profiles of Befotertinib capsules in healthy trial participants. The study consists of two treatment groups.\n\nThe rifampicin group is planned to enroll 18 healthy trial participants. Participants will receive a single oral dose of Befotertinib capsules on the morning of Day 1, and continuous oral administration of rifampicin every morning from Day 19 to Day 27 and Day29 to Day 40. On the morning of Day 28, participants will take Befotertinib capsules and rifampicin.\n\nThe itraconazole group is planned to enroll 18 healthy trial participants to evaluate the effect of itraconazole on the pharmacokinetic profiles of Befotertinib capsules. Participants will receive a single oral dose of Befotertinib capsules on the morning of Day 1, and continuous oral administration of itraconazole every morning from Day 19 to Day 21 and Day 23 to Day 32. On the morning of Day 22 participants will take Befotertinib capsulets and itraconazole.",[85],"DDI (Drug-Drug Interaction)","2026-09-03",{"date":88,"type":89},"2026-09-09","ACTUAL",{"date":91,"type":79},"2026-09",{"date":93,"type":79},"2027-05",{"name":5,"class":6},1]