This is an open label, randomized, balanced, single dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover study of postmenopausal female healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
D-0502 oral tablets
Covance Daytona Beach Clinical Research Unit
Daytona Beach, Florida, United States
Pharmacokinetic: area under the plasma concentration versus time curve (AUC)
AUC: area under the plasma concentration versus time curve for D-0502; Unit: nM\*hr
Time frame: Day 1 through 4, Day 7 through 11
Pharmacokinetic: maximum plasma drug concentration (Cmax)
Cmax: maximum plasma drug concentration of D-0502; Unit: nM
Time frame: Day 1 through 4, Day 7 through 11
Pharmacokinetic: Time to reach the Cmax (Tmax)
Tmax: Time to reach the Cmax of D-0502; Unit: hr
Time frame: Day 1 through 4, Day 7 through 11
Pharmacokinetic: Apparent terminal half-life (t1/2)
t1/2: apparent terminal half-life of D-0502; Unit: hr
Time frame: Day 1 through 4, Day 7 through 11
Incidence of Treatment-Emergent Adverse Events
Number of treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 2 weeks
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