None listed
Conditions
Interventions
Intervention1: Peginterferon alpha 2 b: 1 mcg/kg a day
Control Intervention1: Viraferon Peg injection: 1 mcg/kg a day
Sponsors
Cadila Healthcare Limited,
Zydus Tower, Satellite Road, Ahmedabad, Gujarat
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male subjects aged between 18 and 45 years (including both). 2. Subjects? weight within ±15% of the ideal height-weight chart of Life Insurance Corporation of India for non-medical cases. 3. Ability to communicate effectively with study personnel. 4. Willingness to adhere to the protocol requirements. 5. Able to give consent for participation in the trial. 6. Normal health as determined by personal medical history, clinical examination, and laboratory examinations data during screening(within the clinically acceptable range )
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to Peginterferon alpha 2 b or any other related drug. 2. Preexisting increase in Interferon response marker (baseline serum neopterin concentration). 3. Active liver disease and/or liver transaminases greater than 1.5 X upper limit of normal. 4. Renal insufficiency (serum creatinine > 1.5 mg/dL). 5. History of depression necessitating hospitalisation, two or more recurrent episodes of depression, or suicide attempt. 6. History of epilepsy. 7. History or presence of blood dyscrasias (eg., thrombocytopenia, neutropenia). 8. History or presence of thyroid disorders. 9. History or presence of pulmonary disorders (eg., dyspnoea, pneumonia) 10. History or presence of autoimmune disorders (eg., thyroiditis, rheumatoid arthritis). 11. History or presence of arrhythmia or any other cardiovascular disease. 12. History or presence of eye disorders (e.g., retinal haemorrhage). 13. 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). 14. 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). 15. History or presence of significant alcoholism or drug abuse within the past one-year. 16. History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco products. 17. Difficulty with donating blood. 18. Blood pressure less than 100/60 (Systolic/diastolic) mm Hg or more than 140/90 mm Hg. 19. Pulse less than 60/minute or more than 100/minute. 20. Febrile. 21. Any ECG abnormalities. 22. Major illness during 3 months before the screening period 23. Subjects who have participated in drug research studies within past 3 months. 24. Subjects who have donated one unit (350ml) of blood in the past 3 months. 25. Subjects who are found positive in alcohol breath test and urine test for drug of abuse at the time of check in.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak serum concentration (Cmax), time to reach peak serum concentration (Tmax), area under serum concentration vs. time curve till the last time point (AUC0-t), area under serum concentration vs. time curve extrapolated to the infinity (AUC0-infinity), the residual area in percentage (AUC_% Extrap), serum elimination half-life (t1/2), elimination rate constantTimepoint: For Pharmacodynamic analysis: A total of 10 blood samples will be collected. The venous blood samples will be collected at predose and at 6.00, 12.00, 24.00, 48.00, 72.00, 96.00, 120.00, 144.00 and 168.00 hours following drug administration. For Pharmacokinetic Analysis: A total of 13 blood samples will be collected. The venous blood samples will be withdrawn at predose and at 4.00, 6.00, 8.00, 10.00 12.00, 15.00, 24.00, 48.00, 72.00, 120.00, 168.00, and 192.00 hours following drug administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr RH Jani
Cadila Healthcare Limited
Outcome results
None listed