IRCT20130626013776N8
Completed
未知
Study of the pharmacokinetic and pharmacodynamic and safety properties of Tinapeg® (6 mg/0.6 ml syringes, AryaTinaGene Biopharmaceutical Co) in comparison to Neulastim® (6 mg/0.6 ml syringes, Amgen) in healthy volunteers
AryaTinaGene Biopharmaceutical Co0 sites24 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- AryaTinaGene Biopharmaceutical Co
- Enrollment
- 24
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males, 18\-50 years of age.
- •The subject is able and willing to provide signed 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.
Exclusion Criteria
- •History of allergy or sensitivity to pegfilgrastim.
- •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 the present study.
- •Receipt of any drug as part of a research study within 30 days prior to the present study.
- •Donation or significant loss of whole blood (480 ml or more) within 30 days prior to the present study.
Outcomes
Primary Outcomes
Not specified
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