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Clinical Trial Details

Trial ID: L4047
Source ID: NCT03565458
Associated Drug: Gemigliptin
Title: Gemigliptin, Dapagliflozin, Empagliflozin DDI Study
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Gemigliptin|DRUG: Dapagliflozin|DRUG: Empagliflozin
Outcome Measures: Primary: Area under the plasma concentration versus time curve (AUC) of gemigliptin, dapagliflozin, empagliflozin, AUCτ, day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours|Peak Plasma Concentration (Cmax) of gemigliptin, dapagliflozin, empagliflozin, Css,max, day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours | Secondary: tss,max of gemigliptin, dapagliflozin, empagliflozin, tss,max, day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours|minimum blood plasma concentration of gemigliptin, dapagliflozin, empagliflozin, Css,min, day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours|Area under the plasma concentration versus time curve (AUC) of gemigliptin metabolite, AUCτ, day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours|Peak Plasma Concentration (Cmax)of gemigliptin metabolite, Css,max, day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours|minimum blood plasma concentration(Css,min) of gemigliptin metabolite, Css,min, day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours|metabolic ratio of gemigliptin, metabolic ratio, day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Sponsor/Collaborators: Sponsor: LG Chem
Gender: MALE
Age: ADULT
Phases: PHASE1
Enrollment: 48
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-04-05
Completion Date: 2018-12-22
Results First Posted:
Last Update Posted: 2018-06-21
Locations: LG chem, Seoul, Gangseo-Gu, 07795, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT03565458