| Trial ID: | L6206 |
| Source ID: | NCT01002807
|
| Associated Drug: |
Dapagliflozin
|
| Title: |
Bioavailability Study of Fixed Dose Combination (FDC) Formulations of Dapagliflozin and Metformin XR Versus Individual Component Coadministered to Healthy Subjects in a Fasted State
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus (T2DM)
|
| Interventions: |
DRUG: Dapagliflozin|DRUG: Metformin XR|DRUG: Glucophage
|
| Outcome Measures: |
Primary: Blood samples to measure the pharmacokinetic parameters Cmax and AUC for the combination products versus each investigational product alone, 48 hours post-dose | Secondary: Safety and tolerability measures (adverse events, physical exams, vital signs, ECGs, and clinical laboratory assessments), 15 timepoints in 48 hours time interval
|
| Sponsor/Collaborators: |
Sponsor: AstraZeneca | Collaborators: Bristol-Myers Squibb
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
15
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose:
|
| Start Date: |
2009-11
|
| Completion Date: |
2010-01
|
| Results First Posted: |
|
| Last Update Posted: |
2016-10-17
|
| Locations: |
Ppd Development, Lp, Austin, Texas, 78744, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01002807
|
