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Clinical Trial Details

Trial ID: L7369
Source ID: NCT02648854
Associated Drug: Ckd-395 0.5(Lobeglitazone)/1000(Metformin)Mg 1t
Title: Investigate the Effect of Food on the Pharmacokinetic Characteristics of CKD-395 in Healthy Male Volunteers
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type II
Interventions: DRUG: CKD-395 0.5(Lobeglitazone)/1000(Metformin)mg 1T|DRUG: CKD-395 0.5(Lobeglitazone)/1000(Metformin)mg 1T
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|AUClast of Metformin, 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 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|Cmax of Metformin, 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 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|AUCinf of Metformin, 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 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|Tmax of Metformin, 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs|t1/2 of Metformin, 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs|CL/F of Metformin, 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs|Vd/F of Metformin, 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 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: 2015-10
Completion Date: 2015-11
Results First Posted:
Last Update Posted: 2016-02-08
Locations: Chonbuk National University Hospital, Deokjin-gu, Jeonju-si, Jeollabuk-do, 561-712, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT02648854

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details