Administration study for the human granulocyte-colony stimulating factor (G-CSF) to healthy Japanese adult males

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080222641

Enrollment

Registered

2014-10-30

Start date

2014-11-05

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

investigational material(s) Generic name etc : Neutrogin Injection 50mcg INN of investigational material : Lenograstim Therapeutic category code : 339 Other agents relating to blood and body fluides D

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Sex:Male Age:20 or more years old, less than 40 years old. Weight:50 kg or more. BMI The weight (kg) / height (m) 2 :17.6 or more and less than 26.4(at the time of a prior inspection). There is consent to clinical test participation.

Exclusion criteria

Exclusion criteria: Hypersensitivity to drugs, A history of alcohol or drug addiction, Under the medical treatment or it may treatof a certain disease, Ethical or OTC pharmaceuticals administered within two weeks before scheduled administation of the study drug, Supplement, grapefruit or its products, or foods cotaing Western St. John's comsumed within one week before scheduled administation of the study drug, and Not less than 200mL of blood is collected within 30 days or not less than 400mL of blood is collected within 90 days before scheduled administation of the study drug,

Design outcomes

Primary

Measure	Time frame
other The analysis methods are evaluated by examining the detectable period of the unchanged drug and the metabolites of the test drug.	—

Secondary

Measure	Time frame
other The effect on changes in biological markers is confirmed.	—

Countries

Japan

Outcome results