[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651132":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":33,"centralContacts":37,"locations":43,"responsibleParty":63,"collaborators":33,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":33,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":33,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":33,"overallStatus":46,"whyStopped":33,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","INDUSTRY",[8,15,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Sequence A of bioequivalence study.","EXPERIMENTAL","In Period 1, subjects receive the new formulation; in Period 2, the Phase III formulation; in Period 3, the new formulation; and in Period 4, the Phase III formulation.",[13,14],"Drug: Ammoxetine hydrochloride Enteric-coated Tablets(new formulation)","Drug: Ammoxetine hydrochloride Enteric-coated Tablets(Phase III formulation)",{"label":16,"type":10,"description":17,"interventionNames":18},"Sequence B of bioequivalence study.","In Period 1, subjects receive the Phase III formulation; in Period 2, the new formulation; in Period 3, the Phase III formulation; and in Period 4, the new formulation",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Sequence C of food effect study.","In Period 1, the new formulation is administered under fasting conditions; in Period 2, the new formulation is administered 1 hour after a high-fat meal.",[13],{"label":24,"type":10,"description":25,"interventionNames":26},"Sequence D of food effect study.","In Period 1, the new formulation is administered 1 hour after a high-fat meal; in Period 2, the new formulation is administered under fasting conditions.",[13],[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Ammoxetine hydrochloride Enteric-coated Tablets(new formulation)","oral administration.",[9,16,20,24],null,{"type":29,"name":35,"description":31,"armGroupLabels":36,"otherNames":33},"Ammoxetine hydrochloride Enteric-coated Tablets(Phase III formulation)",[9,16],[38],{"name":39,"role":40,"phone":41,"phoneExt":33,"email":42},"Clinical Trials Information Group officer","CONTACT","031169085587","ctr-contact@cspc.cn",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Suzhou Municipal Hospital","RECRUITING","Suzhou","Jiangsu","215000","China","CN",{"type":53,"coordinates":54},"Point",[55,56],120.59538,31.30408,{"lat":56,"lon":55},[59],{"name":60,"role":40,"phone":61,"phoneExt":33,"email":62},"Mengdie, Ph.D","86-13915574700","cmd_1988@163.com",{"type":64,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100651132","phase-1-evaluation-of-bioequivalence-and-food-effect-of-a-new-strength-formulation-of-ammoxetine-hydrochloride-enteric-coated-tablets-in-healthy-participants-100651132",false,"NCT07756996","Evaluation of Bioequivalence and Food Effect of a New Strength Formulation of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Participants.","Inclusion Criteria:\n\n1. Adults aged 18 \\~65 years (inclusive), male or female;\n2. Body weight ≥ 45.0 kg (female) or ≥ 50.0 kg (male), body mass index (BMI) in the range of 19.0 \\~ 28.0 kg\u002Fm2 (inclusive);\n3. Participants with normal results or abnormal results without clinical significance in medical history, vital signs, physical examination, laboratory tests (including hematology, blood biochemistry, urinalysis, coagulation function, and related tests), chest X-ray, and other examinations.\n4. Participants and their partners must use effective non-hormonal contraceptive measures (e.g., condoms, inert intrauterine devices, etc.) from 2 weeks before screening until 6 months after the end of the study, unless they have already undergone permanent sterilization (e.g., bilateral tubal ligation, vasectomy, etc.). Participants must also refrain from donating sperm or eggs;\n5. Participants who voluntarily sign the informed consent form and are willing to comply with the protocol to complete the study.\n\nExclusion Criteria:\n\n1. Participants with a history of allergic constitution (allergic to two or more drugs, foods, or pollens);\n2. Participants with psychiatric disorders, hepatic or renal dysfunction, gastrointestinal disorders, neurological disorders, or other systemic diseases;\n3. Participants with orthostatic hypotension (a decrease in systolic blood pressure of ≥20 mmHg or diastolic blood pressure of ≥10 mmHg upon standing compared to the supine position);\n4. Participants with a QTcF interval exceeding the upper limit of normal (males \\>450 ms or females \\>470 ms) on 12-lead ECG, or clinically significant abnormalities on a ECG as judged by the investigator, or a history of arrhythmia, syncope associated with arrhythmia, use of a cardiac pacemaker, or other cardiac conditions. Note: Cardiac conditions include, but are not limited to: heart failure; hypokalemia; atrial fibrillation, atrial flutter, atrial premature beats, ventricular premature beats, non-sustained or sustained ventricular tachycardia; bradycardia or sick sinus syndrome; personal or family history of any cardiac conduction abnormalities; personal or family history of long QT syndrome (LQTS); or family history of sudden cardiac death;\n5. Heavy smokers or heavy drinkers (consumption of 14 units of alcohol per week within 4 weeks prior to screening: 1 unit = 285 mL beer, or 25 mL spirits, or 150 mL wine; smoking ≥5 cigarettes per day) or those with a history of other substance or drug abuse within the past year;\n6. Participants with a positive alcohol breath test or positive urine drug screen at screening;\n7. Participants with blood donation or blood loss exceeding 200 mL within 8 weeks prior to screening;\n8. Participants who have participated in another clinical trial of an investigational drug within 3 months prior to screening;\n9. Participants who habitually consumed excessive caffeinated beverages or foods within 4 weeks prior to screening (e.g., coffee, tea, chocolate, cola, energy drinks) with a daily caffeine intake exceeding 6 units. (1 caffeine unit = 1 cup of coffee \\[177.4 mL\\] = 2 cans of cola \\[354.9 mL\\] = 1 cup of tea \\[354.9 mL\\] = 1\u002F2 can of energy drink = 85 g of chocolate);\n10. Participants who used strong or moderate inhibitors of the drug-metabolizing enzyme (CYP2D6) within 4 weeks prior to screening\n11. Participants who habitually consumed dragon fruit, mango, grapefruit, pomelo, sour orange, starfruit, pomegranate, or food\u002Fbeverages prepared from these fruits within 7 days prior to screening;\n12. Participants who used prescription drugs, over-the-counter drugs, herbal products, vitamins, or minerals within 2 weeks prior to screening, or failed to complete at least 5 half-lives of elimination for previously used drugs, whichever is longer;\n13. Participants who used any psychotropic drugs or psychoactive substances within 1 year prior to screening (psychoactive substances include central nervous system depressants, stimulants, hallucinogens, opioids, volatile solvents, novel psychoactive substances, etc.);\n14. Pregnant or lactating women, or female participants with a positive pregnancy test at screening;\n15. Participants with a history of surgery that affects the in vivo disposition of drugs, or any surgery within 3 months prior to screening, or planned surgery during the study period;\n16. Participants who have hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption (history of diarrhea after drinking milk);\n17. Participants with any other condition deemed by the investigator as unsuitable for participation in this study, or withdrawal of consent for personal reasons.",true,"ALL","18 Years","65 Years",{"count":76,"type":77},62,"ESTIMATED","INTERVENTIONAL",[80],"PHASE1","Evaluation of Bioequivalence and Food Effect of a New Strength Formulation of Ammoxetine hydrochloride Enteric-coated Tablets in Healthy Participants.The study is composed of 2 parts. Part 1 is a bioequivalence study with administration 1.5 hours after a high-fat meal, using a randomized, open-label, single-dose, four-period fully replicated design. Part 2 is a food effect study using a single-center, open-label, single-dose, two-period crossover design.",[83],"Healthy Participants","2026-08-10",{"date":86,"type":87},"2026-08-11","ACTUAL",{"date":89,"type":87},"2026-07-15",{"date":91,"type":77},"2026-10-31",{"name":5,"class":6},1]