Drug-drug Interaction Study of FYU-981 and Oxaprozin
- Registration Number
- NCT03350386
- Lead Sponsor
- Mochida Pharmaceutical Company, Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Concomitant administration Oxaprozin Concomitant administration of FYU-981 with oxaprozin at steady state Single dose FYU-981 Single administration of FYU-981 Concomitant administration FYU-981 Concomitant administration of FYU-981 with oxaprozin at steady state
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
P-One Clinic
🇯🇵Hachiōji, Tokyo, Japan