[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100191024":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":11,"locations":18,"responsibleParty":25,"collaborators":11,"id":27,"slug":28,"hasResults":29,"nctId":30,"briefTitle":31,"officialTitle":32,"acronym":11,"eligibilityCriteria":33,"healthyVolunteers":34,"sex":35,"minAge":36,"maxAge":37,"enrollmentInfo":38,"targetDuration":11,"studyType":41,"phases":42,"briefSummary":44,"conditions":45,"keywords":11,"overallStatus":48,"whyStopped":11,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":52,"completionDateStruct":11,"leadSponsor":54,"locationsCount":55},{"fullName":5,"class":6},"PharmaKing","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"PMK-S005","EXPERIMENTAL",null,[13],"Drug: PMK-S005",[15],{"type":16,"name":9,"description":11,"armGroupLabels":17,"otherNames":11},"DRUG",[9],[19],{"facility":20,"status":11,"city":21,"state":22,"zip":23,"country":24,"countryCode":11,"cosmosGeoPoint":11,"geoPoint":11,"contacts":11},"Chungnam national university hospital","Daejeon","Chungcheongnam-do","301-721","South Korea",{"type":26,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100191024","phase-1-a-clinical-trial-to-investigate-the-safety-tolerability-pharmacokinetics-and-food-effect-of-pmk-s005-after-oral-administration-in-healthy-male-volunteers-100191024",false,"NCT01762397","A Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of PMK-S005 After Oral Administration in Healthy Male Volunteers","A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of PMK-S005 After Oral Administration in Healthy Male Volunteers","Inclusion Criteria:\n\n* Male 20 year ≤ age ≤ 40 year.\n* Weight ≥ 55kg, IBW ±20%.\n* Patients with normal hematology, biochemistry, urinary result.\n* Patients who have not congenital or chronic disease.\n* Provision of written informed consent voluntarily.\n\nExclusion Criteria:\n\n* Patients having known hypersensitivity to any component of the study drug.\n* Patients with a history of abnormal digestive organ, kidney, respiratory, neuroendocrine, cardiovascular, hemato-oncology, urinary, muscloskeletal, immune, the nose and ears, psychiatry, stomach system.\n* Patients with any gastrointestinal disorders.\n* Systolic blood pressure ≥ 150 or ≤ 90 mmHg, Diasolic blood pressure ≥ 95 or ≤ 50 mmHg.\n* Drug abuser, alcoholic.\n* Patients taking ETC medication within 14 days, OTC within 7 days.\n* Patients taking other investigational product within 60 days prior to the participation in the study.",true,"MALE","20 Years","40 Years",{"count":39,"type":40},37,"ESTIMATED","INTERVENTIONAL",[43],"PHASE1","The Purpose of a randomized, double-blind, placebo-controlled, single-dose, dose-escalation clinical trial is to explore investigate the safety, tolerability, pharmacokinetics, and food effect of PMK-S005 after oral administration in healthy male volunteers.",[46,47],"Gastritis","Gastric Ulcer","COMPLETED","2014-05-29",{"date":51,"type":40},"2014-05-30",{"date":53,"type":11},"2012-12",{"name":5,"class":6},1]