None listed
Conditions
Interventions
Intervention1: pegG-CSF pegfilgrastim: 6 mg single dose administered via SC route
Control Intervention1: Neulasta® (Amgen): 6 mg single dose administered via SC route
Sponsors
Apotex Inc
Apotex Research Pvt Limited
Eligibility
Inclusion criteria
Inclusion criteria: • Signed informed consent obtained before any trial-related activities. (Trial activities are any procedures that would not have been performed during normal management of the subject). • Ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study. • Healthy male volunteer subjects, 18 to 45 years old, weighing >= 50 kg with BMI of 22.0 to 26.0 kg/m2. • Non smokers for at least 6 months prior to start of screening. • Normal findings in medical history, physical examination, X-ray chest, upper abdominal sonography (no splenomegaly) and ECG unless the investigator considers an abnormality to be clinically irrelevant. • Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant.
Exclusion criteria
Exclusion criteria: • Treatment with an investigational drug within one month prior to study start. • Blood donations during the 3 month prior to study start. • Recent infection (within 1 week), as endogenous G-CSF levels increase in acute inflammation. [Hollenstein et al. 2000]. • Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin,haematological, endocrine, inflammatory or neurological diseases that may interfere with the aim of the study. • Ascertained or presumed hypersensitivity to the active principle and/or formulationsingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may compromise the safety of the volunteers. • Medical history of psoriasis, other dermatoses, sickle cell disorders, and malaria. • Clinically relevant abnormal laboratory values indicative of physical illness. • Use of prescription or over the counter drugs including vitamins within 2 weeks prior to study start, which the investigator considers may affect the validity of the study. • History of drug or alcohol abuse within 6 months prior to study start. • Clinically relevant ECG (12 leads) abnormalities. • Symptoms of a clinically relevant illness in the 3 weeks before the first trial day. • Signs of dermatitis or skin anomalies affecting the administration area and the surroundings. • A positive screen for hepatitis B surface antigens, hepatitis C antibodies, HIV 1 and 2, Reactive Plasma Reagin and Tuberculosis or any other significant abnormality in chest X ray. • Volunteer not suitable for participation in the study in the opinion of Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation and comparison of AUC between test and reference pegfilgrastim medicinal productsTimepoint: 15 days in each Period | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation and comparison of the absolute neutrophil count (ANC). Evaluation and comparison of Cmax and Thalf. Timepoint: 15 days in each Period | — |
Countries
India
Contacts
Public ContactRamalingam Senthil
Apotex Research Pvt. Limited
Outcome results
None listed