Type 2 Diabetes Mellitus
Conditions
Brief summary
The purpose of this study is to estimate the absolute oral bioavailability of dapagliflozin.
Interventions
DRUGDapagliflozin
Tablet and IV solution, Oral and IV, 10 mg po and 100 µg IV, Single oral dose followed by a single IV dose (IV dose administered at 1h after oral dose), 1 day
Sponsors
Bristol-Myers Squibb
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subjects (ages 18 to 45) as determined by medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations will be eligible to participate in the study
Exclusion criteria
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations * Participation in a radiolabeled investigational study drug trial within 12 months prior to admission to the clinical facility * Exposure to significant radiation within 12 months prior to admission to the clinical facility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute oral bioavailability | Within the 3 days after study drug administration |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events (AE) | Within the 3 days after study drug administration |
| Vital signs | Within the 3 days after study drug administration |
| Clinical safety labs | Within the 3 days after study drug administration |
| Electrocardiograms (ECGs) | Within the 3 days after study drug administration |
Countries
United States
Outcome results
None listed