Healthy volunteers.
Conditions
Interventions
Intervention 1: Intervention group: A subcutaneous injection of a single dose of 6 mg of Tinapeg produced by AryaTinaGene Biopharmaceutical Co. to healthy volunteers. Intervention 2: Intervention gro
Sponsors
AryaTinaGene Biopharmaceutical Co
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum concentration of pegfilgrastim. Timepoint: Before and 4, 8, 12, 16 (day 1), 24, 36 (day 2), 48, 60 (day 3) and 72 (day 4) and 96 h (day 5) after injection. Method of measurement: ELISA method with special kit.;Absolute neutrophil count. Timepoint: Before the study drug injection and at 4, 8, 12, 16 (day 1), 24, 36 (day 2), 48, 60 (day 3), 72, 84 (day 4), 96 (day 5), 144 (day 7), 192 (day 9), 240 (day 11), and 312 (day 14) h post-injection. Method of measurement: Cell counter. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach maximum serum concentration. Timepoint: Before and 4, 8, 12, 16 (day 1), 24, 36 (day 2), 48, 60 (day 3) and 72 (day 4) and 96 h (day 5) after injection. Method of measurement: From drug serum concentration-time curve.;Time to reach maximum absolute neutrophil count. Timepoint: Before the study drug injection and at 4, 8, 12, 16 (day 1), 24, 36 (day 2), 48, 60 (day 3), 72, 84 (day 4), 96 (day 5), 144 (day 7), 192 (day 9), 240 (day 11), and 312 (day 14) h post-injection. Method of measurement: From absolute neutrophil count-time curve. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHossein Amini
Gorgan University of Medical Sciences
Outcome results
None listed