Logo 1 Logo 2

Clinical Trial Details

Trial ID: L1810
Source ID: NCT02854748
Associated Drug: Empagliflozin 25mg
Title: Evaluate the Drug-drugs Interaction Between Lobeglitazone and Empagliflozin
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type II
Interventions: DRUG: Empagliflozin 25mg|DRUG: Lobeglitazone 0.5mg|DRUG: Empagliflozin 25mg/Lobeglitazone 0.5mg
Outcome Measures: Primary: AUC0-t,ss of Empagliflozin, Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours|Cmax,ss of Empagliflozin, Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours|AUC0-t,ss of Lobeglitazone, Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours|Cmax,ss of Lobeglitazone, Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours | Secondary: Tmax,ss of Empagliflozin, Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours|t1/2,ss of Empagliflozin, Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours|AUCinf of Empagliflozin, Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours|Tmax,ss of Lobeglitazone, Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours|t1/2,ss of Lobeglitazone, Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours|AUCinf of Lobeglitazone, Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours
Sponsor/Collaborators: Sponsor: Chong Kun Dang Pharmaceutical
Gender: MALE
Age: ADULT
Phases: PHASE1
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2016-08
Completion Date: 2016-09
Results First Posted:
Last Update Posted: 2016-08-09
Locations: Dong A University Hospital, Seo-gu, Busan, 49201, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT02854748

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress