CTRI/2011/12/002221 [Registered on: 13/12/2011] Trial Registered Retrospectively
Last Modified On:
13/12/2011
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A clinical trial to study the pharmacokinetics and pharmacodynamics of Interferon beta 1 b compared with Betaferon, in healthy, adult, male, human subjects.
Scientific Title of Study
Open label,balanced,randomized,two-treatments,single-dose,parallel,comparative subcutaneous pharmacokinetic and pharmacodynamic study of Interferon Beta 1 b 0.5 mg of M/S Cadila Healthcare Ltd.,Ahmedabad,India with Betaferon containing 0.5 mg Interferon Beta 1 b of Schering(PTY) Ltd, Germany in healthy, adult, male, human subjects.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
Project No.:057/08
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr kevinkumar Kansagra
Designation
Associate Research Scientist
Affiliation
Cadila Healthcare Limited
Address
Zydus Research Centre, Cadila Healthcare Limited
Survey No. 396/403,
Sarkhej-Bavla N.H. No. 8A, Moraiya Cadila Healthcare Limited
Zydus Cadila House,
Plot No. 360, TPS 5,
Dayaldas Road - Service Road Crossing
Ahmadabad GUJARAT 382213 India
Phone
02717665555
Fax
02717665355
Email
kevinkumarKansagra@zyduscadila.com
Details of Contact Person Scientific Query
Name
DrRHJani
Designation
Sr V P
Affiliation
Cadila Healthcare Limited
Address
Zydus Cadila House, 2nd floor, Plot No.360,T.P.S. 5, Service road, Vile Parle (East), Zydus Research Centre, Cadila Healthcare Limited
Survey No. 396/403,
Sarkhej-Bavla N.H. No. 8A, Moraiya Mumbai MAHARASHTRA 400057 India
Phone
022-26186052
Fax
022-26151735
Email
rhjani@zyduscadila.com
Details of Contact Person Public Query
Name
DrRHJani
Designation
Sr V P
Affiliation
Cadila Healthcare Limited
Address
Zydus Cadila House, 2nd floor, Plot No.360,T.P.S. 5, Service road, Vile Parle (East), Zydus Research Centre, Cadila Healthcare Limited
Survey No. 396/403,
Sarkhej-Bavla N.H. No. 8A, Moraiya Mumbai MAHARASHTRA 400057 India
Phone
022-26186052
Fax
022-26151735
Email
rhjani@zyduscadila.com
Source of Monetary or Material Support
Zydus Research Center, Cadila Healthcare Limited, Ahmedabad
Ambulatory patients with relapsing-remitting multiple sclerosis ,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Betaferon of Schering Ltd.
0.5 mg single subcutaneous dose i.e. 0.25 mg to be administered over the left and right side of lower abdomen S.C.
Intervention
Interferon Beta 1 b of Cadila healthcare Ltd
0.5 mg single subcutaneous dose i.e. 0.25 mg to be administered over the left and right side of lower abdomen S.C.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Male
Details
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 )
ExclusionCriteria
Details
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.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To compare the pharmacokinetic and pharmacodynamic behavior of Interferon beta 1 b 0.5 mg of Cadila healthcare Ltd, India with Betaferon 0.5 mg of Schering (Pvt) Ltd, Germany in
healthy human subjects.
To monitor the safety and tolerability of Interferon beta 1 b in healthy human subjects.
For PK Analysis: The venous blood samples will be withdrawn at pre-dose and at 0.50, 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 12.00,
16.00, 24.00, 36.00 and 48.00 hours following drug administration.
For PD Analysis: The venous blood samples will be collected at predose and at 0.50,1.00, 2.00, 3.00, 4.00, 6.00, 12.00, 24.00, 48.00, 72.00, 96.00, 120.00, 144.00, and 168.00 hours following drug administration.
Clinic al Safety Measures: Vital signs like sitting blood pressure and radial pulse will be measured and recorded during subject check-in, prior to
administration of dose, 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00,
12.00, 24.00 and 36.00 hours after the administration of dose and at checkout.
Secondary Outcome
Outcome
TimePoints
NIL
NIL
Target Sample Size
Total Sample Size="28" Sample Size from India="28" Final Enrollment numbers achieved (Total)= "" Final Enrollment numbers achieved (India)=""
Phase of Trial
N/A
Date of First Enrollment (India)
27/06/2011
Date of Study Completion (India)
Date Missing
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="0" Months="4" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Completed
Publication Details
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This is an open label,balanced,randomized,two-treatments,single-dose,parallel,comparative subcutaneous pharmacokinetic and pharmacodynamic study of Interferon Beta 1 b 0.5 mg of M/S Cadila Healthcare Ltd.,Ahmedabad,India with Betaferon containing 0.5 mg Interferon Beta 1 b of Schering(PTY) Ltd, Germany in healthy, adult, male, human subjects. The objective of this study is to compare the PK/PD behaviour of interferon beta 1 b 0.5 mg of Cadila healthcare Ltd.,India with betaferon 0.5 mg of Schering Ltd.,Germany and to monitor the safety and tolerability of Interferon beta 1 b in healthy human subjects. A total of 28 adult, male, human subjects will be enrolled in this study and analysed for pharmacokinetic and pharmacodynamic study.