PK Study of Dapagliflozin in Pediatric Subjects With T2DM
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- AstraZeneca
- Study ID
- NCT01525238
- Phase
- PHASE1
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 10 Years - 17 Years
- Healthy Volunteers
- Not accepted
Interventions
- Dapagliflozin — DRUGTablet, Oral, 2.5 mg, Single-dose
- Dapagliflozin — DRUGTablet, Oral, 5 mg, Single-dose
- Dapagliflozin — DRUGTablet, Oral, 10 mg, Single-dose
Study Details
The primary purpose of this study is to evaluate the pharmacokinetics (PK) of Dapagliflozin in pediatric subjects with type 2 diabetes mellitus (T2DM)
Key Dates
- Start date
- Jul 1, 2012
- Status verified
- Apr 2017
- Primary completion
- Sep 1, 2014
- Completion
- Sep 1, 2014
Study Design
- Enrollment
- 53 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- OTHER
Arms
- Experimental: Dapagliflozin 2.5 mg
- Experimental: Dapagliflozin 5 mg
- Experimental: Dapagliflozin 10 mg
Primary Outcome Measure
Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin [ Time Frame: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose ]
Locations (14)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The Children Hospital Of Alabama | Birmingham | Alabama | 35233 | - |
| Axis Clinical Trials | Los Angeles | California | 90036 | - |
| Nemours Childrens Hospital | Orlando | Florida | 32827 | - |
| Emory University | Atlanta | Georgia | 30322 | - |
| Kosair Charities Pediatric Clinical Research Unit | Louisville | Kentucky | 40202 | - |
| Lsuhsc-Shreveport | Shreveport | Louisiana | 71103 | - |
| Childrens Mercy Hospital | Kansas City | Missouri | 64108 | - |
| Women And Children'S Hopsital Of Buffalo | Buffalo | New York | 14222 | - |
| Mercy Children'S Hospital | Toledo | Ohio | 43608 | - |
| Promedica Toledo Children'S Hospital | Toledo | Ohio | 43606 | - |
| Children'S Hospital Of Philadelphia | Philadelphia | Pennsylvania | 19104 | - |
| Children'S Hospital Of Pittsburgh Of Upmc | Pittsburgh | Pennsylvania | 15224 | - |
| Methodist Le Bonheur Hlthcare | Memphis | Tennessee | 38103 | - |
| Christus Santa Rosa Childrens Hospital | San Antonio | Texas | 78207 | - |
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