| Trial ID: | L2675 |
| Source ID: | NCT00961480
|
| Associated Drug: |
Sitagliptin Phosphate (+) Metformin Hydrochloride
|
| Title: |
A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Co-administration of Sitagliptin and Metformin as Individual Tablets (0431A-095)
|
| Acronym: |
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| Status: |
COMPLETED
|
| Study Results: |
NO
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| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: sitagliptin phosphate (+) metformin hydrochloride|DRUG: Comparator: metformin 500mg|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: FMI sitagliptin/metformin 50 mg/850 mg FDC tablet|DRUG: Comparator: metformin 1000 mg|DRUG: Comparator: metformin 850 mg
|
| Outcome Measures: |
Primary: The area under the plasma concentration-time curve (AUC) after administration of sitagliptin/metformin (50/500; 50/850; 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets., Up to 72 hours postdose | Secondary: Peak plasma concentration (Cmax) for metformin after administration of sitagliptin/metformin (50/500; 50/850, 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets., Up to 72 hours postdose
|
| Sponsor/Collaborators: |
Sponsor: Merck Sharp & Dohme LLC
|
| Gender: |
ALL
|
| Age: |
ADULT
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| Phases: |
PHASE1
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2007-10
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| Completion Date: |
2007-11
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| Results First Posted: |
|
| Last Update Posted: |
2015-06-09
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| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00961480
|
