| Trial ID: | L1886 |
| Source ID: | NCT01093794
|
| Associated Drug: |
Co-Administration Of 50 Mg Sitagliptin And 500 Mg Metformin
|
| Title: |
Bioequivalence Study of Sitagliptin/Metformin Combination Tablet (MK0431A-122)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01093794/results
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Co-administration of 50 mg sitagliptin and 500 mg metformin|DRUG: sitagliptin/metformin 50 mg/500 mg tablet|DRUG: Co-administration of 50 mg sitagliptin and 850 mg metformin|DRUG: sitagliptin/metformin 50 mg/850 mg tablet
|
| Outcome Measures: |
Primary: Area Under the Curve (AUC(0-t)) for Sitagliptin, AUC (0-t) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg., baseline through 72 hours postdose|Cmax for Sitagliptin and Metformin, Cmax is the peak serum concentration of a therapeutic drug after administration; and is used to determine the rate and extent of drug absorption. Cmax is reported for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg., baseline through 72 hours postdose |
|
| Sponsor/Collaborators: |
Sponsor: Merck Sharp & Dohme LLC
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
28
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2010-04
|
| Completion Date: |
2010-06
|
| Results First Posted: |
2011-06-27
|
| Last Update Posted: |
2015-07-28
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| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT01093794
|
