Pharmacodynamic and pharmacokinetic study of Neutrogen 5 mcg/kg subcutaneous injectio
- Registration Number
- CTRI/2015/12/006415
- Lead Sponsor
- Virchow Biotech Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
i.Provide written informed consent.
ii.Must be healthy, adult human beings within 20 and 45 years of age (both inclusive) weighing at least 50 kg.
iii.Having a body mass index between 18.5 and 29.9 (both inclusive), calculated as weight in Kg/height in m2.
iv.Must be of normal health as determined by medical history, physical examination and laboratory investigation performed within 28 days prior to the commencement of the study. (Laboratory values must be within normal limits or considered by the physician / investigator to be of no clinical significance).
v.Female Subjects
•of child bearing potential practising an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
•surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)
i.Incapable of understanding the informed consent.
ii.Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg.
iii.Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg.
iv.Oral temperature is below 95.0°F or above 98.6°F.
v.Pulse rate below 50/min or above 100/min.
vi.History of hypersensitivity or idiosyncratic reaction to investigational drug product or any other related drugs.
vii.Non-compliance to injections
viii.History of use of rhG-CSF during last week.
ix.Clinically significant abnormal laboratory values especially in terms of ANC, platelet or hemoglobin or liver or renal insufficiency at the time of screening.
x.Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.
xi.Consumption of grapefruit for the past ten days prior to the check-in.
xii.Regular smoker who has a habit of smoking more than nine cigarettes per day and has difficulty in abstaining from smoking during sample collection period.
xiii.Habit of alcoholism and difficulty in abstaining from alcohol during the sample collection period.
xiv.Difficulty in abstaining from xanthene containing food or beverages (like tea, coffee, chocolates and cola drinks) during the sample collection period.
xv.Confirmed positive in alcohol screening.
xvi.Confirmed positive in selected drug of abuse.
xvii.Participated in any other clinical investigation using experimental drug/donated blood in past 90 days before the date of start of study.
xviii.Confirmed positive in urine pregnancy test.
xix.Female detected to be pregnant, breast feeding or who is likely to become pregnant during the study
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method i.To assess and compare the pharmacokinetic and pharmacodynamic properties of Neutrogen (Filgrastim) of Virchow Biotech, India comparing with that of Neupogen (Filgrastim) of Roche, following 5mcg/kg subcutaneous injection in healthy, adult human subjects.Timepoint: 0, 1, 3, 6, 12, 24, 36, 48 and 72 hrs
- Secondary Outcome Measures
Name Time Method Incidence of adverse eventsTimepoint: Day 1 to Day 3