[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100502562":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":26,"locations":27,"responsibleParty":38,"collaborators":26,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":26,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":48,"minAge":49,"maxAge":26,"enrollmentInfo":50,"targetDuration":26,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":26,"overallStatus":59,"whyStopped":26,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},{"fullName":5,"class":6},"Dong Wha Pharmaceutical Co. Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sequence A","EXPERIMENTAL","Period 1: Empagliflozin and Metformin Period 2: DW6014",[13],"Drug: DW6014",{"label":15,"type":10,"description":16,"interventionNames":17},"Sequence B","Period 1: DW6014 Period 2: Empagliflozin and Metformin",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","DW6014","Drug: DW6014 Single oral administration of DW6014 after an overnight fast\n\nDrug: Empagliflozin and Metformin Combination oral administration of Empagliflozin and Metformin after an overnight fast",[9,15],[25],"Empagliflozin and Metformin",null,[28],{"facility":29,"status":26,"city":30,"state":26,"zip":26,"country":31,"countryCode":26,"cosmosGeoPoint":32,"geoPoint":37,"contacts":26},"Chungbuk National University Hospital","Cheongju-si","South Korea",{"type":33,"coordinates":34},"Point",[35,36],127.48972,36.63722,{"lat":36,"lon":35},{"type":39,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100502562","phase-1-this-study-is-to-compare-and-evaluate-the-safety-and-pharmacokinetic-characteristics-pk-after-administration-of-dw6014-and-each-componentempagliflozin-and-metformin-in-healthy-adult-volunteers-in-fast-condition-100502562",false,"NCT05823870","This Study is to Compare and Evaluate the Safety and Pharmacokinetic Characteristics (PK) After Administration of DW6014 and Each Component(Empagliflozin and Metformin) in Healthy Adult Volunteers in Fast Condition.","A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of Fixed-dose Combination of DW6014 and Loose Combination of Each Component in Healthy Adult Volunteers in Fasted Condition","Inclusion Criteria:\n\n* Healthy subjects aged up to 19 years\n* Subjects weighing at least 50.0 kg with a BMI between 18.0 kg\u002Fm2 and 30.0 kg\u002Fm2\n* Subjects with neither congenital nor chronic diseases requiring treatment, and no abnormal symptoms or findings upon medical examination\n* Subjects considered eligible for the study participation in accordance to the results of clinical laboratory tests, vital signs, physical examinations and 12-lead ECG conducted at the time of screening, based on the investigational product (IP) characteristics\n* Subjects who has a full understanding in participation of the study, voluntarily provide a written consent in participation, and give full agreement in following the subject guidelines throughout the entire study period\n\nExclusion Criteria:\n\n* Subjects with any clinically significant hepatic, renal, nervous, respiratory, endocrine, circulatory, tumor, genitourinary, cardiovascular, digestive, musculoskeletal systemic diseases or other medical history\n* Subject with galactose intolerance, Lapp lactase deficience, glucose-galactose malabsorption or other genetic problem\n* Subject following gastrointestinal diseases or gastrointestinal surgery that may affect the absorption of the IP\n* Pregnant subjects with a positive urine HCG(human chorionic gonadotropin) test, or lactating female subjects\n* Subject with a medical history of hypersensitivity reactions (anaphylaxis or antibiotics etc.) to containing empagliflozin and metformin components, formulation additives, and other drugs (aspirin, antibiotics, biguanide drugs, etc.) or clinically significant hypersensitivity reactions\n* Subjects with clinically significant 12-lead ECG findings at the time of screening\n* Subjects with a past history of drug abuse or a positive urine drug test\n* Subjects with SBP(systolic blood pressure) ≥ 150 mmHg or ≤ 90 mmHg; DBP(diastolic blood pressure) ≥ 100 mmHg or ≤ 60 mmHg; Pulse Rate ≤ 40 bpm or ≥ 100 bpm at the time of screening\n* Subjects taking drugs known to significantly induce or inhibit drug metabolizing enzymes, including barbitals within 1 months prior to the first IP administration\n* Subjects who have administered any prescription drugs or herbal medicines that may affect the characteristics of clinical investigational drugs within 2 weeks prior to the first administration date, or have administered any over-the-counter (OTC) or vitamin preparations within 10 days\n* Subjects taking drugs known to significantly induce or inhibit drug metabolizing enzymes, including barbitals within 1 months prior to the first IP administration\n* Subjects who have participated and were given any other study drugs in other clinical study within 6 months prior to the first IP administration\n* Before the first administration date whole blood donation within 2 months or component blood donation within 1 month or received a blood transfusion within 1 month, or the subject who cannot forbid transfusion from the time of obtaining ICF(informed consent form) until PSV(Post-study visit)\n* Subjects who have consistently drunk alcohol within 6 months\n* Subjects who have smoked more than 10 cigarettes\u002Fday on average\n* Subjects who have eaten or cannot refrain from eating grapefruit (grapefruit)-containing food from 48 hours before the first administration until the time of PSV(Post-study visit)\n* Subjects who have consumed or cannot refrain from consuming caffeine-containing food during the period from 24 hours prior to administration of each period to the time of the last blood sampling\n* Subjects who have done and are unable to refrain from strenuous activity\n* Subjects who are planning for pregnancy or not willing to use a medically reliable forms of contraception\n* Subjects otherwise considered ineligible for participation due to other reasons including clinical laboratory test results not mentioned in the inclusion\u002Fexclusion criteria at the investigator's discretion",true,"ALL","19 Years",{"count":51,"type":52},32,"ACTUAL","INTERVENTIONAL",[55],"PHASE1","This study is to compare and evaluate the safety and pharmacokinetic characteristics (PK) after administration of DW6014 and each component in healthy adult volunteers in fast condition.",[58],"Healthy Subjects","COMPLETED","2023-05-24",{"date":62,"type":52},"2023-05-26",{"date":64,"type":52},"2023-02-24",{"date":66,"type":52},"2023-03-20",{"name":5,"class":6},1]