[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"food-effect-in-healthy-volunteers\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:food-effect-in-healthy-volunteers":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100635225","phase-1-a-study-to-evaluate-the-effect-of-food-on-the-bioavailability-of-aj201-and-safety-tolerability-and-pharmacokinetics-of-aj201-in-japanese-and-white-healthy-male-participants-100635225",false,"NCT07549919","A Study to Evaluate the Effect of Food on the Bioavailability of AJ201, and Safety, Tolerability, and Pharmacokinetics of AJ201 in Japanese and White Healthy Male Participants","A Phase 1, Randomized, Single-dose, Open-label, Two-way, Crossover Study to Evaluate the Effect of Food on AJ201, and to Evaluate the Safety, Tolerability, and Pharmacokinetics of AJ201 in Japanese and White Healthy Male Participants","Key Inclusion Criteria:\n\n* Male, non-smokers (no use of tobacco or nicotine products within 3 months prior to Screening), ≥ 18 and ≤ 55 years of age, with body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg\u002Fm2 and body weight ≥ 50.0 kg.\n* Normal renal function at Screening.\n* Healthy as defined by:\n\n  * The absence of clinically significant illness and surgery within 4 weeks prior to study drug administration.\n  * The absence of a clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, depression, attempted suicide, gastrointestinal, renal, hepatic, and metabolic disease.\n* Participants must be either Japanese or White.\n* Able to understand the study procedures and provide signed informed consent to participate in the study.\n\nKey Exclusion Criteria:\n\n* Any clinically significant abnormal finding at physical examination.\n* Clinically significant abnormal laboratory test results or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody, at Screening.\n* Positive urine drug screen, urine cotinine test, or alcohol breath test.\n* History of significant allergic reactions to any drug.\n* Clinically significant ECG abnormalities or vital signs abnormalities at Screening.\n* History of drug abuse of any soft drugs or hard drugs.\n* History of alcohol abuse.\n* History of smoking or uses other nicotine-containing products.\n* Undergone major surgery ≤ 3 months before first study drug administration.\n* History of clinically significant opportunistic infection or serious local infection or significant medical\u002Fsurgical procedure or trauma or any current infection.\n* Use of medications for the timeframes specified in the protocol.\n* Presence of orthodontic braces or orthodontic retention wires, or any physical findings in the mouth or tongue that would interfere with the dosing procedure.",true,"MALE","18 Years","55 Years",{"count":21,"type":22},26,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a Phase 1, randomized, single-dose, open-label, two-way crossover study to evaluate the effect of food on AJ201, and to evaluate the safety, tolerability, and pharmacokinetics of AJ201 in Japanese and White healthy male participants.",[28,29],"Healthy Male Adults","Food Effect in Healthy Volunteers",[28,31,32],"Healthy Volunteers","Food Effect","RECRUITING","2026-04-19",{"date":36,"type":37},"2026-04-24","ACTUAL",{"date":39,"type":37},"2026-04-09",{"date":41,"type":22},"2026-04-27",{"name":43,"class":44},"AnnJi Pharmaceutical Co., Ltd.","INDUSTRY",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":5},"100597570","phase-1-food-effect-on-pk-of-dw-1021-pelubiprofen-45-mg--tramadol-459-mg-in-healthy-adults-100597570","NCT07060209","Food Effect on PK of DW-1021 (Pelubiprofen 45 mg \u002F Tramadol 45.9 mg) in Healthy Adults","A Randomized, Open-label, Single Oral Dose Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Pelubiprofen-Tramadol (DW-1021) Controlled Release Film Coated Tablet (Pelubiprofen 45mg \u002F Tramadol 45.9mg) After Oral Administration in 14 Healthy Adult Vietnamese Male Subjects Under Fed and Fasting Conditions","DW-1021F","Inclusion Criteria:\n\n1. Healthy male subjects aged 20 to 40 years at screening visit\n2. Body Mass Index (BMI) between 18.5 and 24.9 kg\u002Fm²\n3. Body weight greater than 50 kg\n4. Systolic blood pressure between 100 mmHg and 129 mmHg; diastolic blood pressure less than 84 mmHg\n5. Regular heart rate ranging from 60 to 90 beats per minute\n6. No clinically significant medical history or evidence of congenital or chronic diseases, including but not limited to: hypertension, orthostatic hypotension, hypoglycemia when fasting, swallowing difficulties, diabetes, cardiovascular diseases, pulmonary diseases, gastrointestinal diseases, liver insufficiency, renal insufficiency, endocrine disorders, neurological or psychiatric disorders, immunological, hematological, or hereditary diseases, tuberculosis, or infectious diseases\n7. Suitable laboratory test results (hematology, urinalysis, blood chemistry, HCV\u002FAIDS, HBsAg, anti-HCV) and electrocardiogram (ECG) at screening: no pathological findings; clinical laboratory parameters within the normal range or, if outside the normal range, not clinically significant as judged by the investigator\n8. Willing and able to provide written informed consent after being fully informed about the study objectives and possible adverse effects\n9. Agree to use effective contraception from initial administration until 7 days after the last dose of test or reference drugs\n\nExclusion Criteria:\n\n1. Use of drugs that induce or inhibit drug-metabolizing enzymes (e.g., barbiturates) within 30 days prior to administration, or use of any medication that might affect the study within 10 days prior to administration\n2. Participation in any other clinical trial within 3 months prior to screening\n3. Blood donation within 8 weeks prior to drug administration\n4. History of gastrointestinal surgery that may affect drug absorption\n5. History of drug abuse, or use of alcohol, drugs, or tobacco products within 1 year before participation\n6. Known hypersensitivity or allergy to the test or reference drug or their components\n7. Known genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, which are characterized by symptoms like diarrhea and bloating after consuming dairy products\n8. Suffering from dysphagia","45 Years",{"count":56,"type":22},14,[25],"This is a Phase 1, open-label, single-dose crossover study designed to evaluate the effect of food on the pharmacokinetics of DW-1021, a fixed-dose combination tablet containing pelubiprofen 45 mg and tramadol 45.9 mg. Fourteen healthy adult Vietnamese males will each receive DW-1021 once under fasting conditions and once under fed conditions, with a 14-day washout period in between. Blood samples will be collected to assess how food intake affects the absorption and exposure levels of both active ingredients. Safety, including adverse events, laboratory results, vital signs, and ECGs, will be closely monitored throughout the study.",[31,60,29],"Pharmacokinetics",[62,63,64,65],"Pelubiprofen","DW-1021","Tramadol","Food effect","2025-08-22",{"date":68,"type":37},"2025-08-28",{"date":70,"type":22},"2025-09-20",{"date":72,"type":22},"2025-11-25",{"name":74,"class":75},"Haiphong University of Medicine and Pharmacy","OTHER"]