| Trial ID: | L4913 |
| Source ID: | NCT00944450
|
| Associated Drug: |
Sitagliptin Phosphate Anhydrous Formulation
|
| Title: |
Study of the Bioequivalence of Two Tablet Forms of MK0431 (0431-027)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00944450/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Sitagliptin phosphate anhydrous formulation|DRUG: Comparator: sitagliptin phosphate monohydrate form
|
| Outcome Measures: |
Primary: Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin), Area Under the Plasma Concentration-Time Curve and peak concentration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin), Through 72 Hours Following the Administration of the Medication|Peak Plasma Concentration (Cmax) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin), Peak Plasma concentration (Cmax) for the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin), Through 72 Hours Following the Administration of the Medication |
|
| Sponsor/Collaborators: |
Sponsor: Merck Sharp & Dohme LLC
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
12
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2004-08
|
| Completion Date: |
2004-11
|
| Results First Posted: |
2010-04-27
|
| Last Update Posted: |
2015-08-19
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00944450
|