Healyhy subjects
Conditions
Sponsors
CHUGAI PHARMACEUTICAL CO., LTD.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) healthy men of age >= 20 and = 18.5 and < 25.0 at screening [weight (kg) / height (m)2]
Exclusion criteria
Exclusion criteria: (1) Those who participated in other clinical studies within four months or six times of half-life of the investigational drug before administration of the study drug of this study, whichever is longer before the Eldecalcitol starts, and received the Eldecalcitol (including placebo) (2) Those who have corrected serum Ca within the limits of > 10.4 mg/dL or who have uCa/uCr within the limits of > 0.2. (3) Those who have abnormalities which need medical treatment by screening. (4) Those who do not have the will of preventing conception during the start of the investigational drug administration to the end of follow up observation. (5) In addition, those whom the principal investigator or the subinvestigators judged to be unsuitable as a subject of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety pharmacokinetics (1) Pharmacokinetics 1) Time course change in serum concentration of Eldecalcitol 2) Pharmacokinetic parameters of Eldecalcitol in serum Cmax, Tmax, AUClast, AUCinf, MRT, kel, t1/2, CL/F, Vd/F and others (2) Safety 1) Adverse events 2) Clinical laboratory test (hematology. biochemistry, urinalysis, calcium test) 3) All medically significant changes (clinical symptoms, physiological test, standard 12 lead ECG) | — |
Countries
Asia except Japan
Outcome results
None listed