None listed
Conditions
Interventions
Intervention1: Pegfilgrastim manufactured by Intas Pharmaceuticals Ltd: Dose:6 mg
Frequency: Single dose
Duration of treatment: One day
Intervention2: Pegfilgrastim manufactured by Intas Pharmaceuticals Ltd: Dose:3 mg
Duration of treatment: One day
Control Intervention1: Neulasta® of AMGEN®: Dose:6 mg
Duration of treatment: One day
Control Intervention2: Neulasta® of AMGEN®: Dose:3 mg
Sponsors
Intas Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Non-smoking, healthy, normal, adult human volunteers between 18 to 45 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 â?? 24.9 kg/m2 (both inclusive), and weight not 100 kg. 3. Not having any significant disease in medical history or clinically significant abnormal findings during screening, abdominal ultrasonography, medical history, physical examination, laboratory evaluations, 12-lead ECG and X-ray chest (P/A 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. Both male and female patients of child bearing potential must be practicing adequate contraception.Female patients of child-bearing potential must not be orlikely to be pregnant or lactating and must have a negative serum pregnancy test at screening and negative urine pregnancy test at randomization.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to the study drug or its constituents 2. Known case of hereditary fructose intolerance 3. Any clinically significant laboratory 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., haemopoietic, renal, hepatic, cardiovascular, 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 NSAIDs induced urticaria. 6. Subjects with a history of pulmonary infiltrate or pneumonia in the previous 6 months from the date of the screening visit. 7. History of any hematologic disease including sickle cell disorders 8. Receipt of over-the-counter medicines which have not yet cleared from the body (five half-lives must have passed for the medicine to be considered to have cleared from the body). 9. Smokers, or who have smoked within last six months prior to start of the study. 10. Consumption of tobacco or tobacco containing products within last six months prior to start of the study. 11. Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans. 12. The presence of clinically significant abnormal laboratory values during screening. 13. Positive result for human immunodeficiency virus (HIV I &/or II) and/or hepatitis B and C tests. 14. History or presence of psychiatric disorders. 15. Consumption of grape fruit or grape fruit products within 72 hours prior to receiving study drug. 16. A history of difficulty in donating blood.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC0-tTimepoint: Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of drug related Adverse Events as assessed by clinical examination, vitals and/or laboratory parameters for both the treatmentsTimepoint: Day 28 | — |
Countries
India
Contacts
Public ContactDr Tarak Parikh
Lambda Therapeutic Research Ltd
Outcome results
None listed