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Clinical Trial Details

Trial ID: L5216
Source ID: NCT02827890
Associated Drug: Januvia Tab. 100mg
Title: CKD-396 Drug-drug Interaction Study(B) (CKD-396 DDI(B) P1)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus Type 2
Interventions: DRUG: Januvia Tab. 100mg|DRUG: Januvia Tab. 100mg + Duvie Tab. 0.5mg
Outcome Measures: Primary: AUCĪ„ of Sitagliptin, 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h|Css,max of Sitagliptin, 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h | Secondary: Css,min of Sitagliptin, 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h|Css,av of Sitagliptin, 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h|Tss,max of Sitagliptin, 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h|t1/2 of Sitagliptin, 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h|CLss/F of Sitagliptin, 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h|Vdss/F of Sitagliptin, 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h|fluctuation[(Css,max-Css,min)/Css,av] of Sitagliptin, 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h|swing[(Css,max-Css,min)/Css,min] of Sitagliptin, 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
Sponsor/Collaborators: Sponsor: Chong Kun Dang Pharmaceutical
Gender: MALE
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 20
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2016-04
Completion Date: 2016-05
Results First Posted:
Last Update Posted: 2017-08-09
Locations: Chonbuk National University Hospital, Jeonju-si, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT02827890

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress