A clinical trial to study the pharmacokinetics and pharmacodynamics of Interferon beta 1 b compared with Betaferon, in healthy, adult, male, human subjects.
- Conditions
- Health Condition 1: null- Ambulatory patients with relapsing-remitting multiple sclerosis
- Registration Number
- CTRI/2011/12/002221
- Lead Sponsor
- Cadila Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 28
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 )
1.History of hypersensitivity to Interferon beta 1 b or any other related drug or preexisting increase in Interferon response marker (baseline serum neopterin concentration)
2.Active liver disease and/or liver transaminases greater than 1.5 X upper limit of normal or renal insufficiency (serum creatinine 1.5 mg/dL).
3.History of depression necessitating hospitalisation, two or more recurrent episodes of depression, or suicide attempt.
4.History or presence of epilepsy or blood dyscrasias (eg., lyphocytopenia, neutropenia) , thyroid disorders, cardiomyopathy or any other cardiovascular disease, musculo-skeletal disorders (e.g., myopathies, myolysis, etc.), other systemic disorders or diseases (e.g., respiratory, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement).
5.Subjects taking drugs that have a narrow therapeutic index and are largely dependent on the hepatic cytochrome P450 system for clearance, e.g. anti-epileptics, oral anticoagulants etc.
6.History or presence of significant alcoholism or drug abuse within the past one-year or significant smoking (more than 10 cigarettes per day) or consumption of tobacco products or difficulty with donating blood.
7.Blood pressure less than 100/60 (Systolic/diastolic) mm Hg or more than 140/90 mm Hg or pulse less than 60/minute or more than 100/minute.
8.Febrile or any ECG or X-ray abnormalities during screening, major illness during 3 months before the screening period, presence of clinically significant abnormal laboratory values during screening.
9.Subjects who have participated in drug research studies within past 3 months.
10.Subjects who have donated one unit (350ml) of blood in the past 3 months.
11.Subjects who are found positive in alcohol breath test and urine test for drug of abuse at the time of check in.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method