Clinical Trial Details
| Trial ID: | L0567 |
| Source ID: | NCT01976572 |
| Associated Drug: | Colestilan |
| Title: | Drug-Drug Interaction Study to Evaluate the Effect of Colestilan on the Pharmacokinetics of Single Doses of Candesartan Cilexetil in Healthy Subjects |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT01976572/results |
| Conditions: | Hyperphosphatemia|Chronic Kidney Disease |
| Interventions: | DRUG: colestilan|DRUG: candesartan |
| Outcome Measures: | Primary: AUC0-t of Candesartan, Area under the plasma concentration-time curve from time zero up to the last quantifiable time-point, 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose|Cmax of Candesartan, Maximum observed plasma concentration, 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose | Secondary: Tmax, Time of maximum observed plasma concentration, 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose|T1/2, Apparent plasma terminal elimination half-life, 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose |
| Sponsor/Collaborators: | Sponsor: Mitsubishi Tanabe Pharma Corporation |
| Gender: | MALE |
| Age: | ADULT |
| Phases: | PHASE1 |
| Enrollment: | 18 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2013-10 |
| Completion Date: | 2014-01 |
| Results First Posted: | 2015-10-30 |
| Last Update Posted: | 2017-05-12 |
| Locations: | Covance Clinical Research Unit Ltd., Leeds, Springfield House Hyde Street, United Kingdom |
| URL: | https://clinicaltrials.gov/show/NCT01976572 |
