Healthy Volunteers
Conditions
Keywords
Healthy volunteers, Inhibition of glucose re-absorption, diabetes, dapagliflozin
Brief summary
The primary objective of the study is to assess the effect of dapagliflozin on the amount of glucose in the blood and urine when dapagliflozin is administered once a day (10 mg) versus twice a day (5 mg every 12 hours) after five days of dosing.
Interventions
DRUGDapagliflozin
Dapagliflozin tablets 5 mg, Oral Twice daily dose for 5 days (total daily dose 10 mg)
Sponsors
Bristol-Myers Squibb
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Female healthy volunteers must be post-menopausal (cessation of menses \>1year, be surgically sterile (documented) or have undergone hysterectomy) or be sexually abstinent from enrolment until follow-up examination * Have normal physical exam, vital signs ECG findings, and laboratory values
Exclusion criteria
* Use of prescription medication for a chronic or acute medical condition within 3 weeks of randomization * History or presence of neurological, haematological, psychiatric, gastrointestinal, hepatic or renal disease, or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs as determined by the Investigator * Previous participation in an AstraZeneca (AZ) or Bristol-Myers Squibb (BMS) dapagliflozin study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Calculation of derivation of pharmacokinetic variables | Up to 14 blood samples will be obtained on day 1 (with the closest interval between samples being 15 minutes), one sample on days 3 and 4, and up to 21 samples on day 5 |
Secondary
| Measure | Time frame |
|---|---|
| Calculation of derivation of pharmacodynamic variables (inhibition of plasma glucose re-absorption, 24 hour urine glucose excretion, inhibition of rate of gut glucose absorption by measuring plasma glucose, insulin and GIP). | plasma glucose will be drawn on Day 5, creatinine will be drawn at pre-dose of Day 4 and of Day 5, glucose and insulin will be drawn on Day 5 , Day 5 for GIP, urine will be collected on Day 5 in 4-hour intervals |
| To examine the safety and tolerability of the combination of dapagliflozin and metformin | Adverse events and laboratory variables assessed throughout both 5-day treatment periods, and a follow-up visit 5-10 days later |
Countries
Germany
Outcome results
None listed