| Trial ID: | L3147 |
| Source ID: | NCT00961857
|
| Associated Drug: |
Sitagliptin Phosphate (+) Metformin Hydrochloride
|
| Title: |
A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Concomitant Administration of Sitagliptin and Metformin as Individual Tablets (0431A-048)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: sitagliptin phosphate (+) metformin hydrochloride|DRUG: Comparator: metformin 500 mg|DRUG: Comparator: sitagliptin|DRUG: Comparator: FMI sitagliptin/metformin 50 mg/500 mg FDC tablet|DRUG: Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet|DRUG: Comparator: metformin 1000 mg
|
| Outcome Measures: |
Primary: The area under the plasma concentration vs. time curve (AUC) after administration of sitagliptin/metformin (50/500 and 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets, 72 hours post dose | Secondary: Peak plasma concentration (Cmax) of sitagliptin and metformin after administration of sitagliptin/metformin (50/500 and 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets, 72 hours post dose
|
| Sponsor/Collaborators: |
Sponsor: Merck Sharp & Dohme LLC
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
48
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2005-12-01
|
| Completion Date: |
2006-01-01
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| Results First Posted: |
|
| Last Update Posted: |
2019-11-13
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| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00961857
|
