Clinical Trial Details
| Trial ID: | L4091 |
| Source ID: | NCT01330563 |
| Associated Drug: | Ckd-501, Ketoconazole |
| Title: | Drug-drug Interaction Study (CKD-501, Ketoconazole) |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: CKD-501, Ketoconazole |
| Outcome Measures: | Primary: CKD-501 AUC, 0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr | Secondary: CKD-501 Cmax, 0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr|CKD-501 Tmax, 0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr |
| Sponsor/Collaborators: | Sponsor: Chong Kun Dang Pharmaceutical | Collaborators: Severance Hospital |
| 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: | 2011-03 |
| Completion Date: | 2011-06 |
| Results First Posted: | |
| Last Update Posted: | 2011-06-29 |
| Locations: | Severance Hospital, Seoul, 120-752, Korea, Republic of |
| URL: | https://clinicaltrials.gov/show/NCT01330563 |
