Healthy Male and Female Subjects
Conditions
Keywords
Diabetes,NOS
Brief summary
The purpose of the study is to determine the effect of metformin on dapagliflozin exposure and the effect of dapagliflozin on metformin exposure in healthy volunteers. Additionally, the safety and tolerability of dapagliflozin will be assessed in the presence and absence of metformin in healthy volunteers
Interventions
DRUGDapagliflozin
Tablets, Oral, 20 mg, once daily single dose
DRUGMetformin
Tablets, Oral, 1000 mg, once daily, single dose
Tablets, Oral, once daily, single dose Dapagliflozin: 20 mg Metformin: 1000 mg
Sponsors
Bristol-Myers Squibb
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy men and women, ages 18-45 with a body mass index of 18-32 kg/m2
Exclusion criteria
* Unwilling to use acceptable method of birth control * current or recent (within 1 month) smoker * abnormal liver function tests * presence of edema * history of diabetes mellitus * history of heart failure or renal insufficiency * history of chronic or recurrent urinary tract infections, or vulvovaginal mycotic infections * history of Hepatitis C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the effect of metformin on the exposure of dapagliflozin and the effect of dapagliflozin on the exposure of metformin in healthy subjects after a single dose of each treatment | measures taken daily throughout the study |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of dapagliflozin when administered alone or with metformin after a single dose of each treatment | measures will be taken at the beginning and end of the study, as well as 1 time every 3 days (Day -1 of each study period) |
Countries
United States
Outcome results
None listed