| Trial ID: | L3695 |
| Source ID: | NCT01135446
|
| Associated Drug: |
Dapagliflozin
|
| Title: |
Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Ultra Low Doses of Dapagliflozin in Healthy Subjects
|
| Acronym: |
ULDS
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: dapagliflozin|DRUG: dapagliflozin|DRUG: dapagliflozin|DRUG: dapagliflozin|DRUG: dapagliflozin|DRUG: dapagliflozin
|
| Outcome Measures: |
Primary: Total 24-hour Urinary Glucose Excretion as a Measure of Pharmacodynamic Effect, 24 hours after dosing | Secondary: Number of Participants with Adverse Events as a Measure of Safety and Tolerability, 24 hours after dosing|Dapagliflozin and Dapagliflozin 3-O-glucuronide (Metabolite of Dapagliflozin) Concentrations to Characterize Dapagliflozin Pharmacokinetics, 2 days after dosing
|
| Sponsor/Collaborators: |
Sponsor: AstraZeneca | Collaborators: Bristol-Myers Squibb
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
35
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose:
|
| Start Date: |
2010-05
|
| Completion Date: |
2010-06
|
| Results First Posted: |
|
| Last Update Posted: |
2016-10-17
|
| Locations: |
Ppd Development, Lp, Austin, Texas, 78744, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01135446
|
