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Clinical Trial Details

Trial ID: L2410
Source ID: NCT02685774
Associated Drug: Duvie Tab. 0.5mg, Glucophage Xr Tab. 500mg
Title: A Clinical Study to Compare the Pharmacokinetic Characteristics of CKD-395 0.25/500mg in Healthy Male Volunteers
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type II
Interventions: DRUG: Duvie Tab. 0.5mg, Glucophage XR Tab. 500mg|DRUG: CKD-395 0.25/500mg
Outcome Measures: Primary: AUClast of Lobeglitazone, 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs|Cmax of Lobeglitazone, 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs|AUClast of Metformin, 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 and 48hrs|Cmax of Metformin, 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 and 48hrs | Secondary: AUCinf of Lobeglitazone, 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs|Tmax of Lobeglitazone, 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs|t1/2 of Lobeglitazone, 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs|CL/F of Lobeglitazone, 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs|Vd/F of Lobeglitazone, 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs|AUCinf of Metformin, 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 and 48hrs|Tmax of Metformin, 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 and 48hrs|t1/2 of Lobeglitazone, 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 and 48hrs|CL/F of Metformin, 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 and 48hrs|Vd/F of Metformin, 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 and 48hrs
Sponsor/Collaborators: Sponsor: Chong Kun Dang Pharmaceutical
Gender: MALE
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 26
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2016-02
Completion Date: 2016-04
Results First Posted:
Last Update Posted: 2017-08-09
Locations: Chonbuk National University Hospital, Jeonju-si, Jeollabuk-do, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT02685774

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress