Pharmacokinetics Study of Pegfilgrastim
- Registration Number
- CTRI/2022/05/042409
- Lead Sponsor
- upin Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 300
1.Healthy human subjects (both male and female) between 18 to 45 years of age (both inclusive).
2.Subject having a Body Mass Index (BMI) between 18.5 to 29.9 (both inclusive), calculated as weight in kg / height in m�² and body weight of 60 to 100 kg (both inclusive)
3.Subject having normal findings during screening within 21 days prior to administration of study drug, medical history and examination, Clinically acceptable laboratory evaluations, 12-lead ECG and chest X ray
4.Subject having clinically acceptable hepatic function tests (SGOT and SGPT) and an estimated creatinine clearance (CrCL) of >90 mL/min.
5.Subject able to comply with the study procedures in the opinion of the PI/CI/Physician
6.Subject able to give written consent for participation in the study
7.subject is female; currently
non-pregnant, non-lactating, or not attempting to become pregnant,
has a negative serum pregnancy test and is of non-childbearing potential or is of childbearing potential, willing to use acceptable method of birth control or is of childbearing potential and not sexually active, willing to commit to using a consistent and acceptable method of birth control.
8.If male and sexually active, the subject is willing to commit to double-barrier acceptable methods of birth control for the duration of the study or exclusively has same-sex partners
1.Known history of hypersensitivity or idiosyncratic reaction to Pegfilgrastim or any of the excipients in the formulation, and/or hypersensitivity to E. Coli derived proteins.
2.Known history of previous exposure to filgrastim, pegfilgrastim, granulocyte colony stimulating factor (GCSF) or any analogue of these.
3.Subjects with history of latex allergies as the needle cover on the single-use prefilled syringe contains dry natural rubber (latex).
4.Any disease or medical/surgical condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
5.Any clinically significant laboratory findings, including any platelet or haemoglobin result outside the clinically acceptable range.
6.Subjects with a history of pulmonary infiltrate or pneumonia in the previous 6 months prior to administration of IMP.
7.Subject having history of any recent infection (within 1 week), as endogenous G-CSF levels increase in acute inflammation.
8.Subject having medical history of acute myeloid leukemia or splenomegaly at baseline or sickle cell disease or fructose intolerance.
9.Subject who have taken prescribed medication or over-the-counter drug or herbal medication within 14 days prior to administration of IMP.
10.Subject having any history or presence of breathlessness at rest or on exertion or asthma (including aspirin induced asthma) or NSAID induced urticaria.
11.A recent history of alcoholism (120 mL or more per day) and consumption of alcohol and its products or grapefruit and its juice within 48 hours prior to administration of IMP.
12.Subject, who smoke 9 or more cigarettes / day or inability to abstain for at least 24 hours prior to administration of IMP and during the study.
13.Subject who habituated to drinking tea or coffee (more than 5 cups/ day) or inability to abstain from caffeine and /or xanthine products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) for at least 24 hours prior to administration of IMP and during the study.
14.Subject who habituated to tobacco/tobacco containing products / Gutkha (more than 10 gm/day) or inability to abstain for at least 24 hours prior to administration of IMP and during the study.
15.Subject with positive result for hepatitis B & C, HIV antibody and syphilis.
16.Use of any recreational drugs or history of drug addiction or testing positive in pre-study urine drug of abuse.
17.History of difficulty with donating blood.
18.Donation of blood (1 unit: 350 mL / 450 mL) within 90 days prior to administration of IMP.
19.The receipt of an investigational product or participation in a drug research study within a period of 90 days prior to administration of IMP.
20.Subject who vaccinated with live vaccine in last 4 weeks, or expected to require such vaccination during the course of the study.
21.Subject having any kind of significant skin abnormalities in the injection site, such as scar, thick skin, open wounds, tattoos etc, as decided by the physician
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method