[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100249713":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":24,"locations":33,"responsibleParty":46,"collaborators":24,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":24,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":24,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":24,"overallStatus":68,"whyStopped":24,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Adocia","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BioChaperone Lispro U-100","ACTIVE_COMPARATOR","injection of 2 doses of 0.2 U\u002Fkg on separate visits",[13],"Drug: BioChaperone Lispro U-100",{"label":15,"type":16,"description":11,"interventionNames":17},"BioChaperone Lispro U-200","EXPERIMENTAL",[18],"Drug: BioChaperone Lispro U-200",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Injection of BioChaperone Lispro U-100",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Injection of BioChaperone Lispro U-200",[15],[29],{"name":30,"affiliation":31,"role":32},"Grit Andersen, MD","Profil Institut Für Stoffwechselfforschung GmbH","PRINCIPAL_INVESTIGATOR",[34],{"facility":35,"status":24,"city":36,"state":24,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":24},"Profil Institut für Stoffwechselforschung GmbH","Neuss","41460","Germany","DE",{"type":41,"coordinates":42},"Point",[43,44],6.68504,51.19807,{"lat":44,"lon":43},{"type":47,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100249713","phase-1-a-clinical-trial-investigating-the-intra-subject-variability-of-pharmacokinetics-and-glucodynamics-of-biochaperone-insulin-lispro-u-100-product-and-u-200-product-in-healthy-volunteers-100249713",false,"NCT02529293","A Clinical Trial Investigating the Intra-subject Variability of Pharmacokinetics and Glucodynamics of BioChaperone Insulin Lispro U-100 Product and U-200 Product in Healthy Volunteers","A Pilot Clinical Trial Investigating the Intra-subject Variability of Pharmacokinetics and Glucodynamics of BioChaperone Insulin Lispro U-100 Product (2 Single Doses of 0.2 U\u002Fkg) and U-200 Product (2 Single Doses of 0.2 U\u002Fkg) in Healthy Male and Female","Inclusion Criteria:\n\n* Male or female subjects, considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.\n* Age ≥ 18 and ≤ 64 years, both inclusive.\n* Body Mass Index (BMI) between 18.5 and 28.0 kg∙m-2, both inclusive.\n* Fasting Plasma Glucose (FPG) ≤ 5.6 mmol\u002FL (100 mg\u002FdL).\n* Signed and dated informed consent obtained before any trial-related activities, i.e. any procedures that would not have been performed during normal management of the subject).\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to trial product(s) or related products.\n* Receipt of any investigational medicinal product within 3 months before randomisation in this trial.",true,"ALL","18 Years","64 Years",{"count":60,"type":61},26,"ACTUAL","INTERVENTIONAL",[64],"PHASE1","This is a double-blinded, randomised, single-centre phase I pilot trial for exploring the feasibility of a pivotal clinical trial establishing bioequivalence between BioChaperone insulin lispro U-200 and BioChaperone insulin lispro U-100 in healthy subjects.\n\nEach subject will be randomly allocated to a sequence of four treatments, i.e. two single doses of BioChaperone insulin lispro U-200 of 0.2 U·kg BW-1 and two single doses of BioChaperone insulin lispro U-100 of 0.2 U·kg BW-1 on four separate dosing visits.",[67],"Healthy","COMPLETED","2015-12-17",{"date":71,"type":72},"2015-12-18","ESTIMATED",{"date":74,"type":24},"2015-08",{"date":76,"type":61},"2015-11",{"name":5,"class":6},1]