None listed
Conditions
Interventions
Intervention1: Peginterferon alfa-2b: Active content: Recombinant Human Peginterferon alfa-2b
Dose: 1.5 micrograms/kg
Manufacturer: Intas Biopharmaceuticals Ltd.
Pharmaceutical form: Powder for Inject
Sponsors
Intas Biopharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Non-smoking, healthy adult human male 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 ? 24.9 (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 consent for participation in the trial.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity or idiosyncratic reaction to to Peginterferon alpha-2b or any other related drug. 2. Active liver disease and/or SGOT and SGPT greater than 1.5 X upper limit of normal. 3. Renal insufficiency (serum creatinine 1.5 mg/dL). 4. Having clinical significant abnormal laboratory values of platelet count, neutrophils and thyroid function test. 5. History of depression necessitating hospitalization, two or more recurrent episodes of depression or suicide attempt. 6. History of epilepsy. 7. History or presence of blood dyscrasias (e.g., thrombocytopenia, neutropenia), History or presence of thyroid disorders, History or presence of pulmonary disorders (e.g., dyspnoea, pneumonia), History or presence of autoimmune disorders (e.g., thyroiditis, rheumatoid arthritis), History or presence of arrhythmia or any other cardiovascular disease, History or presence of eye disorders (e.g., retinal haemorrhage). 8. 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). 9. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID induced urticaria. 10. Ingestion of a medicine at any time within 14 days before dosing. In any such case subject selection will be at the discretion of the Principal Investigator. 11. Subjects taking drugs that have a narrow therapeutic index (e.g. anti-epileptics etc) and drugs that can depress the immune system (e.g. anti-cancer drugs etc). 12. A recent history of harmful use of alcohol(less than one years), 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. 13. Smokers, or who have smoked within last six months prior to start of the study. 14. Consumption of tobacco or tobacco containing products within last six months prior to start of the study. 15. Use of any recreational drugs or history of drug addiction within the past one year or testing positive in pre-study drug scans. 16. The presence of clinically significant abnormal laboratory values during screening. 17. Blood pressure less than 100/60 (Systolic/diastolic) mm Hg or more than 140/90 mm Hg. 18. Pulse less than 60/minute or more than 100/minute. 19. Fever. 20. Any ECG abnormalities. 21. Major illness during 3 months before the screening period 22. 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. 23. A positive hepatitis screen including hepatitis B surface antigen and HCV antibodies. 24.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetic parameters, Cmax, AUC0-t & AUC0-inf will be measured. Beta 2- microglobulin will be pharmacodynamic parameter which will be measuredTimepoint: samples will be collected upto 336 hours after dosing to measure above parameters | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety parameters during conduct of studyTimepoint: vital signs measurement: pre-dose and at 02.00, 04.00, 10.00 and 36.00 hrs post dose | — |
Countries
India
Contacts
Public ContactDr Alpeshkumar Patel
Lambda Therapeutic Research Ltd
Outcome results
None listed