A study to compare the biological equivalence of Pegfilgrastim manufactured by Apotex and Neulasta® manufactured by Amge
- Registration Number
- CTRI/2012/02/002400
- Lead Sponsor
- Apotex Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 26
• 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.
• 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.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation and comparison of AUC between test and reference pegfilgrastim medicinal productsTimepoint: 15 days in each Period
- Secondary Outcome Measures
Name Time Method Evaluation and comparison of the absolute neutrophil count (ANC). <br/ ><br> <br/ ><br>Evaluation and comparison of Cmax and Thalf. <br/ ><br>Timepoint: 15 days in each Period