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Clinical Trial Details

Trial ID: L2652
Source ID: NCT03616392
Associated Drug: D308, Ckd-501
Title: Clinical Trial to Evaluate the Drug Drug Interaction of CKD-501 and D308
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type II
Interventions: DRUG: D308, CKD-501
Outcome Measures: Primary: (Part 1) AUCss,tau of D308, Area under the curve of D308 at steady state, Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours|(Part 1) Css,max of D308, Max Concentration of D308 at steady state, Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours|(Part 2) AUCss,tau of CKD-501, Area under the curve of CKD-501 at steady state, Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours|(Part 2) Css,max of CKD-501, Max Concentration of CKD-501 at steady state, Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours | Secondary: (Part 1) Css,min of D308, Min concentration of D308 at steady state, Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours|(Part 1) Css,av of D308, average concentration of D308 at steady state, Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours|(Part 1) Tss,max of D308, time of Max concentration of D308 at steady state, Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours|(Part 1) t1/2 of D308, half-life time of D308, Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours|(Part 1) CLss/F of D308, Apparent clearance of D308 at steady state, Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours|(Part 1) Vdss/F of D308, Apparent volume of distribution of D308 at steady state, Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours|(Part 1) Fluctuation[(Css,max-Css,min)/Css,av] of D308, Fluctuation concentration of D308 at steady state, Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours|(Part 1) Swing[(Css,max-Css,min)/Css,min] of D308, Swing concentration of D308 at steady state, Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours|(Part 2) Css,min of CKD-501, Min concentration of CKD-501 at steady state, Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours|(Part 2) Css,av of CKD-501, average concentration of CKD-501 at steady state, Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours|(Part 2) Tss,max of CKD-501, time of Max concentration of CKD-501 at steady state, Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours|(Part 2) t1/2 of CKD-501, half-life time of CKD-501, Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours|(Part 2) CLss/F of CKD-501, Apparent clearance of CKD-501 at steady state, Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours|(Part 2) Vdss/F of CKD-501, Apparent volume of distribution of CKD-501 at steady state, Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours|(Part 2) Fluctuation[(Css,max-Css,min)/Css,av] of CKD-501, Fluctuation concentration of CKD-501 at steady state, Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours|(Part 2) Swing[(Css,max-Css,min)/Css,min] of CKD-501, Swing concentration of CKD-501 at steady state, Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
Sponsor/Collaborators: Sponsor: Chong Kun Dang Pharmaceutical
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 41
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-07-25
Completion Date: 2018-11-13
Results First Posted:
Last Update Posted: 2018-11-19
Locations: Chonbuk National University Hospital, Jeonju, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT03616392