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Plasma Concentration, Excretion and Mass Balance Orally Administered 14C-FYU-981 in Healthy Male Subjects
To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites of FYU-981 after a single 1 mg oral dose of 14C-FYU-981 in healthy male subjects.
Details
| Lead sponsor | Fuji Yakuhin Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 6 |
| Start date | 2016-09 |
| Completion | 2018-07 |
Conditions
- Healthy Male Subjects
Interventions
- 14C-FYU-981
Primary outcomes
- Pharmacokinetics (Cmax: Maximum plasma concentration) — 168 hours
- Pharmacokinetics (AUC: Area under the plasma concentration-time curve) — 168 hours
- Pharmacokinetics (Tmax: Time to reach the peak plasma concentration) — 168 hours
- Pharmacokinetics (T1/2: Elimination half-life of plasma concentration) — 168 hours
- Pharmacokinetics (kel: Elimination rate constant) — 168 hours
- Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed — 168 hours
Countries
Japan