This study is to investigate the effect of food on the pharmacokinetics, the pharmacodynamics and safety of ASP1941 after administration of ASP1941 in healthy non-elderly adult male subjects.
This will be a randomized, open-label, 3-way crossover design study to investigate the effect of food on the pharmacokinetics, the pharmacodynamics and safety of ASP1941 after administration of ASP1941 in healthy non-elderly adult male subjects. Each subject will receive a single dose of ASP1941 "under fasting condition", "before meal" and "after meal".
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
30
oral
Unnamed facility
Kantou, Japan
Pharmacokinetics (PK) profiles of ASP1941 (in plasma): AUCinf, AUClast and Cmax
Area under the curve (AUC) from time 0 extrapolated to infinity (AUCinf), AUC from time of dosing to last quantifiable concentration (AUClast ), and maximum concentration (Cmax)
Time frame: For 72 hours after each administration
Pharmacokinetics (PK) profiles of ASP1941 (in plasma): tmax, t1/2, apparent distribution volume, apparent body clearance
Time to attain Cmax (tmax) , apparent terminal elimination half-life (t1/2 )
Time frame: For 72 hours after each administration
Safety assessed by incidence of adverse event, vital signs, 12-lead ECG and laboratory tests
Time frame: For 72 hours after each administration
Changes in urinary glucose excretion
Time frame: Before and for 72 hours after each administration
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