Clinical Trial Details
| Trial ID: | L2366 |
| Source ID: | NCT00924430 |
| Associated Drug: | Simvastatin- Slv337 Sd Beta- Slv337 Sd Alpha - Slv337 Md Beta- Slv337 Sd Beta+ Simvastatin |
| Title: | Interaction Study SLV337/Simvastatin |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: Simvastatin- SLV337 SD beta- SLV337 SD alpha - SLV337 MD beta- SLV337 SD beta+ Simvastatin|DRUG: Simvastatin - SLV337 SD alpha - SLV337 SD beta - SLV337 MD beta - SLV337 SD beta+ Simvastatin |
| Outcome Measures: | Primary: Simvastatin and simvastatin acid: Cmax, tmax, AUC0-t, AUC, lz, and t1/2, as well as CL/F and Vz/F for simvastatin only, 20 days | Secondary: SLV337 and its acylglucuronide metabolite: Cmax, tmax, AUC0-24, AUC0-t, CL/F (SLV337 only) on Days 1 and 13, as well as AUC, lz, t1/2 and Vz/F (SLV337 only) on Day 1, 20 days|Safety and tolerability assessments including adverse events, clinical laboratory tests, electrocardiogram (ECG) and vital signs, During the duration of study participation |
| Sponsor/Collaborators: | Sponsor: Solvay Pharmaceuticals |
| Gender: | MALE |
| Age: | ADULT |
| Phases: | PHASE1 |
| Enrollment: | 16 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2009-06 |
| Completion Date: | 2009-07 |
| Results First Posted: | |
| Last Update Posted: | 2009-09-09 |
| Locations: | Site 1, London, United Kingdom |
| URL: | https://clinicaltrials.gov/show/NCT00924430 |
