| Trial ID: | L3098 |
| Source ID: | NCT00930865
|
| Associated Drug: |
Bumetanide
|
| Title: |
Study to Evaluate the Potential Pharmacokinetic Interaction and Pharmacodynamic Effects on Renal Parameters of Bumetanide (1mg) and Dapagliflozin (10 mg) When Co-administered in Healthy Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Bumetanide|DRUG: Dapagliflozin
|
| Outcome Measures: |
Primary: Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs, 24 hours post-dose on Day 8 and 15 | Secondary: To assess the safety and tolerability of bumetanide and dapagliflozin following multiple oral doses of 1 mg bumetanide and 10 mg dapagliflozin, administered together, either simultaneously or after adaptation to either agent alone, in healthy subjects, during 14 days of dosing|Explore potential pharmacodynamic (serum/urine electrolytes) effects of bumetanide + dapagliflozin following multiple doses of 1 mg bumetanide + 10 mg dapagliflozin, administered together, either simultaneously or after adaptation to either agent alone, during 14 days of dosing
|
| Sponsor/Collaborators: |
Sponsor: AstraZeneca | Collaborators: Bristol-Myers Squibb
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
42
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2009-07
|
| Completion Date: |
2009-09
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| Results First Posted: |
|
| Last Update Posted: |
2016-10-17
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| Locations: |
Ppd Development, Lp, Austin, Texas, 78744, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00930865
|
