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Clinical Trial Details

Trial ID: L6625
Source ID: NCT02002611
Associated Drug: Lobeglitazone
Title: Drug-drug Interaction Study(Lobeglitazone, Warfarin)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Lobeglitazone|DRUG: Warfarin
Outcome Measures: Primary: Assess AUC of lobeglitazone, 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h|Assess Cmax of lobeglitazone, 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h|Assess AUC of S-warfarin, 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h|Assess Cmax of S-warfarin, 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h|Assess AUC of R-warfarin, 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h|Assess Cmax of R-warfarin, 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h | Secondary: Assess tmax of lobeglitazone, 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h|Assess t1/2 of lobeglitazone, 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h|Assess CL/F of lobeglitazone, 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h|Assess Vd/F of lobeglitazone, 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h|Assess tmax of S-warfarin, 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h|Assess t1/2 of S-warfarin, 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h|Assess CL/F of S-warfarin, 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h|Assess Vd/F of S-warfarin, 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h|Assess tmax of R-warfarin, 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h|Assess t1/2 of R-warfarin, 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h|Assess CL/F of R-warfarin, 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h|Assess Vd/F of R-warfarin, 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h
Sponsor/Collaborators: Sponsor: Chong Kun Dang Pharmaceutical
Gender: MALE
Age: ADULT
Phases: PHASE1
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2013-12
Completion Date: 2014-05
Results First Posted:
Last Update Posted: 2014-07-03
Locations: Samsung Medical Center, Seoul, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT02002611

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D194 Warfarin small molecule DB00682 Details