Healthy
Conditions
Brief summary
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.
Interventions
DRUGFYU-981
Single administration
DRUGOxaprozin
Repeated administration
Sponsors
Fuji Yakuhin Co., Ltd.
Mochida Pharmaceutical Company, Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult healthy subjects * Body mass index: \>=18.5 and \<25.0
Exclusion criteria
* Subject with any disease or any history of disease that might be unsuitable for participation in the clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (Cmax: Maximum plasma concentration) | 48 hours |
| Pharmacokinetics (Tmax: Time to reach the peak plasma concentration) | 48 hours |
| Pharmacokinetics (T1/2: Elimination half-life of plasma concentration) | 48 hours |
| Pharmacokinetics (AUC: Area under the plasma concentration-time curve) | 48 hours |
| Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed) | 48 hours |
| Pharmacokinetics (kel: Elimination rate constant) | 48 hours |
| Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed) | 48 hours |
| Pharmacokinetics (MRT: Mean residence time) | 48 hours |
| Safety (Incidence of treatment-emergent adverse event) | 20 days |
Countries
Japan
Outcome results
None listed