The purpose of this study is to determine whether AZD1656 will affect the pharmacokinetics (PK) of digoxin in type 2 diabetes mellitus (T2DM) patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Research Site
Chula Vista, California, United States
evaluate the pharmacokinetics of digoxin after a single dose when administered alone and in combination with AZD1656 at steady state, by assessment of AUC and Cmax of digoxin
Time frame: Serial PK blood samples will be taken on days 4-8 during the treatment periods
evaluate the safety of AZD1656 in combination with digoxin by assessment of electrocardiogram, weight, pulse, blood pressure, laboratory variables (including 7-point glucose), physical examination and adverse events.
Time frame: Safety assessments will be monitored throughout the study, from screening visit until follow up visit.
describe the pharmacokinetics of AZD1656 and its metabolite during concomitant digoxin administration by assessment of AUC(0-24), Cmax, Ctrough, tmax, t1/2 and CL/F (AZD1656 only).
Time frame: Serial PK blood samples will be taken on days 4-8 during the treatment periods
describe the pharmacokinetics of digoxin when administered alone or in combination with AZD1656 by assessment of tmax and t1/2.
Time frame: Serial PK blood samples will be taken on days 4-8 during the treatment periods
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.