[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100399070":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":20,"responsibleParty":21,"collaborators":20,"id":23,"slug":24,"hasResults":25,"nctId":26,"briefTitle":27,"officialTitle":28,"acronym":20,"eligibilityCriteria":29,"healthyVolunteers":30,"sex":31,"minAge":32,"maxAge":33,"enrollmentInfo":34,"targetDuration":20,"studyType":37,"phases":38,"briefSummary":40,"conditions":41,"keywords":20,"overallStatus":43,"whyStopped":20,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":20},{"fullName":5,"class":6},"Sihuan Pharmaceutical Holdings Group Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"1","EXPERIMENTAL","Administered orally once",[13],"Drug: [14C]-Anaprazole Sodium enteric-coated capsule",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","[14C]-Anaprazole Sodium enteric-coated capsule","\\[14C\\]-Anaprazole Sodium enteric-coated capsule",[9],null,{"type":22,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100399070","phase-1-open-label-study-to-assess-the-absorption-metabolism-excretion-and-mass-balance-of-a-single-oral-dose-of-14c-20-mg100-ci-anaprazole-sodium-enteric-coated-capsule-in-healthy-adult-male-subjects-100399070",false,"NCT04476394","Open-label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Oral Dose of [14C]-20 mg\u002F100 μCi Anaprazole Sodium Enteric-coated Capsule in Healthy Adult Male Subjects","A Single-center, Open, Single Dose Mass Balance Study to Assess the Absorption, Metabolism, Excretion of [14C]-20 mg\u002F100 μCi Anaprazole Sodium Enteric-coated Capsule in Chinese Health Adult Male Subjects","Inclusion Criteria:\n\n* 1.The subject is a Chinese adult male, aged 18 to 45 years, inclusive.\n* 2.The subject weighed at least 50.0 kg and had a body mass index (BMI) between 19.0 kg\u002Fm\\^2 and 26.0 kg\u002Fm\\^2, inclusive.\n* 3\\. Participants with evaluations of vital signs, physicial examination results,clinical laboratory and ECG testing outside the reference range that are deemed not clinically significant at investigator discretion at screening.\n* 4.The subject with childbearing potential agrees that the subject and his sexual partner use adequate contraception from signing of informed consent throughout the duration of the study and for 6 months after study completion.\n* 5.The subject is capable of understanding and complying with protocol requirements, and signed and dated a written informed consent form voluntarily\n\nExclusion Criteria:\n\n* 1.Has clinical significant drug allergy or allergic disease history(Such as asthma, urticaria, eczema dermatitis, etc), or has hypersensitivity or allergy to investigatory drugs or related supplements；\n* 2.Has clinical significant ECG abnormal history or family history of long QT syndrome(Grandparents, parents and siblings)\n* 3.Any disease or medical history that may significantly affect the absorption, distribution, metabolism, and excretion of drugs, or any condition that may pose a hazard to the subject. Such as:\n\n  * Inflammatory bowel disease, gastric ulcer, duodenal ulcer, gastrointestinal \u002F rectal bleeding, persistent nausea, or other clinically significant gastrointestinal abnormalities;\n  * Has suffered from gastrointestinal diseases or complications that may affect the absorption of drugs (ie: malabsorption, gastroesophageal reflux, peptic ulcer, erosive esophagitis, frequent heartburn) within 6 months before screening or had history of gastrointestinal surgery (for example: gastrectomy, gastrointestinal anastomosis, intestinal resection, gastric bypass, gastric segmentation or gastric banding, cholecystectomy, except for appendicitis surgery and proctectomy);\n  * Evidence of liver disease or clinically impaired liver function at the time of screening (eg AST, ALT or total bilirubin\\> 1.5 times ULN);\n  * A history or evidence of nephropathy or renal insufficiency at the time of screening, showing clinically significant abnormality of creatinine or abnormal urine composition (such as proteinuria, creatinine\\> 176.8 umol \u002F L, etc.)\n  * Has difficulty swallowing oral preparations.\n* 4.Thyroid stimulating hormone (TSH)\\> ULN; or serum free triiodothyronine (FT3)\\> ULN; or serum free thyroxine (FT4)\\> ULN at the time of screening;\n* 5\\. Frequent smokers and alcoholics within 3 months before screening (smoke more than 5 cigarettes \u002F day, drink more than 21 units of alcohol per week, 1 unit = 360 mL beer or 45 mL liquor or 150 mL wine), or can't stop using any tobacco products, and alcohol intake during the study period ; or those who have a positive alcohol breath test before enrollment;\n* 6\\. Has received any investigational compound (including post-marketing investigational drugs) or participated in clinical trials of any drugs \u002Fdevices within 3 months before screening;\n* 7\\. A history of drug abuse within 12 months before screening or a positive urine test result at screening;\n* 8\\. Has used any prescription drugs, non-prescription drugs (including chemical drugs, vitamin drugs, Chinese herbal medicines, etc.) within 4 weeks before administration of investigational drugs;\n* 9\\. Has taken foods that affect CYP3A4 (such as grapefruit or beverages containing grapefruit) within 2 weeks before administration of investigational drugs;\n* 10\\. Human immunodeficiency virus antibody, hepatitis B surface antigen, hepatitis C antibody, and Treponema pallidum specific antibody test results were positive at screening;\n* 11\\. Has difficulty in venous blood collection or halo acupuncture;\n* 12.Blood donation \u002F blood loss ≥200 mL within 1 month, or ≥400 mL within 3 months before screening; or has blood donation plan during the period of medication of investigational drugs and within 3 months after drug withdrawal;\n* 13\\. Has special dietary requirements and cannot follow the unified dietary arrangements;\n* 14\\. Has particpated in another clinical study with radioactive labeling within 1 year before administration.\n* 15\\. Has significant radiation exposure (Radiation exposure from chest X-ray, CT scan or barium meal examination more than once, or be engaged in radiation related occupations) within 1 year before administration.\n* 16\\. Any conditions in which considered by investigator not be appropriate to participate in this trial.",true,"MALE","18 Years","45 Years",{"count":35,"type":36},6,"ESTIMATED","INTERVENTIONAL",[39],"PHASE1","This is an open-label, single-dose, absorption, metabolism, excretion, and mass balance study following a single oral dose of \\[14C\\]-20 mg\u002F100 μCi Anaprazole Sodium enteric-coated capsule in healthy adult male subjects. Whole blood, plasma samples will be collected at hour 0 pre-dose and 1，2，3，4，5，6，8，12，24，48，72，96，120，144，168 hours post-dose (tentative, adjusted according to plasma drug concentration); urine samples will be collected at hour 24 pre-dose and 0-4，4-8，8-12，12-24，24-48，48-72，72-96，96-120，120-144，144-168，168-192，192-216，216-240 hours post-dose (tentative, adjusted according to sample recovery rate) ; fecal samples will be collected at hour 24 pre-dose and 0-24，24-48，48-72，72-96，96-120，120-144，144-168，168-192，192-216，216-240 hours post-dose (tentative, adjusted according to sample recovery rate) following the start of administration to measure total radioactivity and plasma drug concentrations.",[42],"Healthy Male Volunteers","UNKNOWN","2020-07-15",{"date":46,"type":47},"2020-07-20","ACTUAL",{"date":49,"type":36},"2020-08-03",{"date":51,"type":36},"2020-09-30",{"name":5,"class":6}]