Healthy
Conditions
Brief summary
This is a randomized, open-label, 2-period crossover study. The purpose of this study is to assess the pharmacokinetics and safety after single oral administration of final formulation of FYU-981 to healthy male adults in fasted and fed conditions. Participants are randomized to fasted (n=6) or fed conditions (n=6) in each step. The effect of food to pharmacokinetics of FYU-981 is also investigated.
Interventions
DRUGFYU-981
Single administration of FYU-981 under Fasted and fed conditions in the morning.
Sponsors
Fuji Yakuhin Co., Ltd.
Mochida Pharmaceutical Company, Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Japanese healthy adult subjects * Body mass index: \>=18.5 and \<25.0
Exclusion criteria
* Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (Cmax: Maximum plasma concentration) | 48 hours | — |
| Pharmacokinetics (Tmax: Time to reach the peak plasma concentration) | 48 hours | — |
| Pharmacokinetics | 48 hours | T1/2: Elimination half-life of plasma concentration |
| 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 events) | 13 days | — |
Countries
Japan
Outcome results
None listed