Bioequivalence Study of Filgrastim in Healthy Human Volunteers
- Conditions
- Healthy volunteers.
- Registration Number
- IRCT20130626013776N7
- Lead Sponsor
- AryaTinaGene Biopharmaceutical Co
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 24
Males, 18-50 years of age.
The subject is able and willing to provide written informed consent.
The subject is available for the entire study period and is willing to adhere to protocol requirements as evidenced by written informed consent.
The subject has stable residence and telephone.
Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
History of allergy or sensitivity to filgrastim.
history of any drug hypersensitivity or intolerance which, in the opinion of the investigator,would compromise the safety of the subject of the study.
Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction.
Presence of gastrointestinal disease or history of malabsorption within the last year.
History of a medical disorders occurring within the last year that required hospitalization or medication
Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing.
Receipt of any drug as part of a research study within 30 days prior to dosing.
Donation or significant loss of whole blood (480 ml or more) within 30 days prior to dosing.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum concentration of filgrastim. Timepoint: Before and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 h after injection. Method of measurement: ELISA method with special kit.;Absolute neutrophil count. Timepoint: Before and at 4, 8, 10, 12, 16, 24, 36, 48, 72, and 96 h post-injection. Method of measurement: Cell counter.
- Secondary Outcome Measures
Name Time Method Time to reach maximum serum concentration. Timepoint: Before and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 h after injection. Method of measurement: From drug serum concentration-time curve.;Time to reach maximum absolute neutrophil count. Timepoint: Before and at 4, 8, 10, 12, 16, 24, 36, 48, 72, and 96 h post-injection. Method of measurement: From absolute neutrophilcount-time curve.