[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100336217":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":35,"locations":36,"responsibleParty":50,"collaborators":52,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":35,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":35,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":35,"overallStatus":75,"whyStopped":35,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Conjupro Biotherapeutics, Inc.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Test Drug - Reference Product - Test Drug (Food Effect)","OTHER","In Part 1, this group of subjects were treated with a single dose of 5 mg levamlodipine maleate tablets (Test Product), then crossed over to receive a single dose of 10 mg Amlodipine Besylate Tablet NORVASC® (Reference Product) under fasted conditions. After a wash-out period for 14-days, all subjects were rolled over to Part 2 where they received a single dose of 5 mg levamlodipine maleate tablets under a high-fat\u002Fhigh-calorie meal to assess food effect.",[13,14],"Drug: Levamlodipine, Amlodipine","Drug: Amlodipine, Levamlodipine",{"label":16,"type":10,"description":17,"interventionNames":18},"Reference Product - Test Drug - Test Drug (Food Effect)","In Part 1, this group of subjects were treated with a single dose of 10 mg Amlodipine Besylate Tablet NORVASC® (Reference Product), and then crossed over to receive a single dose of 5 mg levamlodipine maleate tablets (Test Product) under fasted conditions. After a wash-out period for 14-days, all subjects were rolled over to Part 2 where they received a single dose of 5 mg levamlodipine maleate tablets under a high-fat\u002Fhigh-calorie meal to assess food effect.",[13,14],[20,26],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":24},"DRUG","Levamlodipine, Amlodipine",[16,9],[25],"Xuanning®, NORVASC®",{"type":21,"name":27,"description":17,"armGroupLabels":28,"otherNames":29},"Amlodipine, Levamlodipine",[16,9],[30],"NORVASC®, Xuanning®",[32],{"name":33,"affiliation":5,"role":34},"Study Officials","STUDY_DIRECTOR",null,[37],{"facility":38,"status":35,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":35},"Collaborative Neuroscience Network, LLC","Long Beach","California","90806","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-118.18923,33.76696,{"lat":48,"lon":47},{"type":51,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR",[53],{"name":54,"class":6},"CSPC Ouyi Pharmaceutical Co., Ltd.","100336217","phase-1-bioavailability-of-5-mg-of-levamlodipine-maleate-tablets-versus-10-mg-of-amlodipine-besylate-tablet-in-healthy-subjects-100336217",false,"NCT03657550","Bioavailability of 5 mg of Levamlodipine Maleate Tablets Versus 10 mg of Amlodipine Besylate Tablet in Healthy Subjects","Randomized Open-label Single-Dose Two-Way Crossover Study to Assess the Relative Bioavailability of 5mg Levamlodipine Tablet vs. 10mg Amlodipine Besylate Tablet in Healthy Subjects Followed by a Phase to Study Food Effect on the PK of Levamlodipine","Key Inclusion Criteria:\n\n1. Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening and be practicing a medically acceptable method of contraception with an annual failure rate of less than 1% during the study and 60 days after discontinuation of study treatment.\n2. Considered healthy by the Principal Investigator, based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG and vital signs;\n3. Nonsmoker, defined as not having smoked or used any form of tobacco in more than 6 months before screening;\n4. Body mass index (BMI) of 19 to 30 kg\u002Fm2 inclusive and body weight not less than 50 kg;\n\nExclusion Criteria:\n\n1. Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity;\n2. Mean systolic blood pressure of three measurements \\>140 mmHg, or a mean diastolic blood pressure of three measurements \\>90 mmHg at screening.\n3. Known or suspected malignancy;\n4. Positive blood screen for human immunodeficiency virus (HIV), or hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV);\n5. A history of seizure. However, a history of febrile seizure is allowed;\n6. Positive pregnancy test result, or plan to become pregnant if female;\n7. A hospital admission or major surgery within 30 days prior to screening;\n8. Participation in any other investigational drug trial within 30 days prior to screening;\n9. DSM-V substance use disorder within 6 months prior to screening;\n10. A positive result for alcohol or drugs of abuse at screening or admission;\n11. Tobacco use within 6 months prior to screening;\n12. An unwillingness or inability to comply with food and beverage restrictions during study participation;\n13. Donation or blood collection of more than 1 unit (approximate 450 mL) of blood (or blood products) or acute loss of blood during the 90 days prior to screening;\n14. Use of prescription or over-the-counter (OTC) medications, and herbal medicines (including St John's Wort, herbal teas, garlic extracts) within 14 days prior to dosing;\n15. A history of suicide attempt in the past 12 months and\u002For seen by the investigator as having a significant history of risk of suicide or homicide;\n16. A history of intolerance or hypersensitivity to amlodipine or any excipients;\n17. An unwillingness of male participants to use appropriate contraceptive measures if engaging in sex intercourse with a female partner of childbearing potential during the study and 60 days after discontinuation of study treatment.",true,"ALL","18 Years","45 Years",{"count":67,"type":68},36,"ACTUAL","INTERVENTIONAL",[71],"PHASE1","This study are (1) to assess the relative bioavailability (BA) of a single oral dose of either 5 mg of Levamlodipine Maleate Tablets from CSPC or 10 mg of Amlodipine Besylate Tablet (NORVASC®) from Pfizer Inc. under fasting condition in male and female healthy subjects; and (2) to evaluate food effect on the PK profile of Levamlodipine Maleate Tablets from CSPC.",[74],"Hypertension","COMPLETED","2021-09-09",{"date":78,"type":68},"2021-09-16",{"date":80,"type":68},"2018-05-31",{"date":82,"type":68},"2018-09-06",{"name":5,"class":6},1]