This is an open-label, 2-period add-on study to assess the drug-drug interaction between FYU-981 and oxaprozin. The purpose of this study is to investigate the pharmacokinetics of each period in a single administration of FYU-981 and concomitant administration of FYU-981 with oxaprozin at steady -state in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
P-One Clinic
Hachiōji, Tokyo, Japan
Pharmacokinetics (Cmax: Maximum plasma concentration)
Time frame: 48 hours
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
Time frame: 48 hours
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
Time frame: 48 hours
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
Time frame: 48 hours
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
Time frame: 48 hours
Pharmacokinetics (kel: Elimination rate constant)
Time frame: 48 hours
Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)
Time frame: 48 hours
Pharmacokinetics (MRT: Mean residence time)
Time frame: 48 hours
Safety (Incidence of treatment-emergent adverse event)
Time frame: 20 days
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