Clinical Trial Details
| Trial ID: | L3553 |
| Source ID: | NCT00929201 |
| Associated Drug: | Sitagliptin Phosphate/Metformin Hydrochloride Fdc |
| Title: | Sitagliptin/Metformin Fed Bioequivalence Study (0431A-080) |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00929201/results |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: Sitagliptin phosphate/metformin hydrochloride FDC|DRUG: Sitagliptin phosphate|DRUG: Metformin hydrochloride |
| Outcome Measures: | Primary: Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin, Serum samples were used to determine the AUC from time 0 to infinity for metformin., Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose | Secondary: Peak Plasma Concentration (Cmax) of Metformin, Serum samples were used to determine the maximum concentration for metformin., Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose |
| Sponsor/Collaborators: | Sponsor: Merck Sharp & Dohme LLC |
| Gender: | ALL |
| Age: | ADULT |
| Phases: | PHASE1 |
| Enrollment: | 61 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2008-01 |
| Completion Date: | 2008-05 |
| Results First Posted: | 2010-02-01 |
| Last Update Posted: | 2015-08-13 |
| Locations: | |
| URL: | https://clinicaltrials.gov/show/NCT00929201 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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