None listed
Conditions
Interventions
Intervention1: Pegfilgrastim of Intas
Biopharmaceuticals Ltd.: Active content: Pegfilgrastim
Dose: 6mg/0.6 ml
Manufacturer: Intas Biopharmaceuticals Ltd. India
Pharmaceutical form: Pre filled syringe
Sponsors
Intas Biopharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Non-smoking, healthy, normal, adult human volunteers between 18 to 55 years of age (both inclusive) living in and around Ahmedabad city or western part of India. 2. Having a Body Mass Index (BMI) between 18.5 ? 30.0 (both inclusive), calculated as weight in kg / height in meter2. 3. Not having any significant disease in medical history or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, 12- lead ECG and X-ray chest (postero-anterior view) recordings. 4. Ability to communicate effectively with study personnel. 5. Willingness to adhere to the protocol requirements. 6. Able to understand and give written informed consent for participation in the trial. 7. In case of female subjects: a. Surgically sterilized at least 6 months prior to study participation; Or b. If of child bearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study.And c. Pregnancy test must be negative.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity or idiosyncratic reaction to pegfilgrastim or any other related drug. 2. Subjects with latex allergies will be excluded as the needle cover on the single-use prefilled syringe contains dry natural rubber (latex). 3. Any clinically significant lab finding including ANC (Absolute Neutrophil Count), CD 34+, platelet or hemoglobin at the time of screening. 4. History or presence of other systemic disorders or diseases (e.g., respiratory, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement). 5. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID induced urticaria. 6. Ingestion of a medicine at any time within 1 month prior to start of the study. In any such case subject selection will be at the discretion of the Principal Investigator. 7. A recent history of harmful use of alcohol, i.e. alcohol consumption of more than 14 standard drinks per week (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within 72 hours prior to receiving study medicine. 8. Smokers, or who have smoked within last six months prior to start of the study. 9. Consumption of tobacco or tobacco containing products within last six months prior to start of the study. 10. Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans. 11. The presence of clinically significant abnormal laboratory values during screening. 12. Donation of blood (1 unit or 350 mL) or receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication. Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study. Note: In case the blood loss is ¡Ü 200 mL; subject may be dosed 60 days after blood donation or last sample of the previous study. 13. A positive hepatitis screen including hepatitis B surface antigen and HCV antibodies. 14. A positive test result for HIV antibody. 15. History of psychiatric disorders. 16. Presence of tattoo or scars or wound at the proposed site. 17. An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the study medicine. In any such case subject selection will be at the discretion of the Principal Investigator. 18. Consumption of grape fruit or grape fruit products within 72 hours prior to receiving study drug. 19. A history of difficulty in donating blood. 20. Testing positive for pregnancy test (females) 21. Nursing mothers (females)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess and compare Pegfilgrastim of Intas Biopharmaceuticals Ltd. based on pharmacokinetic and pharmcodynamic parameters following s.c. injection of a single dose of 6mg/0.6 ml against NEULASTIM of ROCHE in healthy, normal, adult, human, subjects.Timepoint: predose & 2.000, 4.000, 6.000, 8.000, 10.000, 12.000, 14.000, 16.000, 18.000, 20.000, 24.000, 30.000, 36.000, 48.000, 72.000, 96.000, 120.000, 144.000, 168.000, 192.000, 216.000, 240.000, 264.000, 288.000, 312.000, 336.000, 360.000 hours post dose | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety of the subjects.Timepoint: Pre-dose and at 02.00, 04.00, 10.00, 24.00, 30.00 and 36.00 hrs post dose | — |
Countries
India
Contacts
Public ContactPrashant Modi
nil
Outcome results
None listed