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Clinical Trial Details

Trial ID: L6150
Source ID: NCT04869800
Associated Drug: Ckd-398
Title: Evaluate the Drug-drugs Interaction Between Lobeglitazone 0.5mg and Empagliflozin 25mg
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: CKD-398|DRUG: CKD-501, D745
Outcome Measures: Primary: AUCt of CKD-398, Area under the plasma concentration time curve of CKD-344, from time zero up to the last measurable concentration., predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose|Cmax of CKD-398, The maximum concentration observed of CKD-344 over blood sampling time., predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose | Secondary: AUCinf of CKD-398, Area under the concentration-time curve from zero up to ∞, predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose|Tmax of CKD-398, Time to maximum plasma concentration, predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose|T1/2 of CKD-398, Terminal elimination half-life, predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose|CL/F of CKD-398, Apparent Clearance, predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose|Vd/F of CKD-398, Apparent volume of distribution, predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose
Sponsor/Collaborators: Sponsor: Chong Kun Dang Pharmaceutical
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 32
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-05-27
Completion Date: 2021-06-15
Results First Posted:
Last Update Posted: 2021-08-25
Locations: Chonbuk National University Hospital, Jeonju, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT04869800