Administration study for the human granulocyte-colony stimulating factor (G-CSF) to healthy Japanese adult males
- Conditions
- ot applicable
- Registration Number
- JPRN-jRCT1080222641
- Lead Sponsor
- Mitsubishi chemical Medience Corporation
- Brief Summary
For healthy adult men, one of the test drug Neutrogin injection, Gran injection solution, or Neuup injection was subcutaneously injected into the upper arm, and blood samples and urine samples were collected before and after administration of the test drug. Using this, changes in blood parameters due to G-CSF, changes in metabolites in the sample, and detectable period were confirmed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 9
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.
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,
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method