| CTRI Number |
CTRI/2010/091/001220 [Registered on: 30/08/2010] |
| Last Modified On: |
21/05/2019 |
| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
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A clinical trial to compare the effects of two drugs, Peginterferon alpha 2 b 1 microgram/kg of M/s. Cadila Healthcare Ltd and Viraferon Peg containing 1 microgram/kg Peginterferon alpha 2 b of Schering Plough in healthy volunteers |
Scientific Title of Study
Modification(s)
|
Open label, balanced, randomized, two-treatments, single-period, single-dose, parallel, comparative subcutaneous pharmacodynamic and pharmacokinetic study of peginterferon alpha 2 b 1 microgram/kg of m/s Cadila Healthcare Ltd., Ahmedabad, India with Viraferon Peg containing 1 microgram/kg peginterferon alpha 2 b of Schering Plough, Ireland in healthy, adult, male, human subjects |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| Project No.: 036/08 |
Other |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tanvi Shah |
| Designation |
|
| Affiliation |
|
| Address |
Clinical Research Department, Zydus Research Centre
Sarkhej-Bavla N. H. No. 8 A, Moraiya
Ahmadabad
GUJARAT
382 213
India |
| Phone |
91-2717-250801-5 |
| Fax |
|
| Email |
tanvishah@zyduscadila.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr RH Jani |
| Designation |
Sr. Vice President, Clinical R&D |
| Affiliation |
Cadila Healthcare Limited |
| Address |
Zydus Cadila House,
Plot No. 360, TPS 5, Service Road, Vile Parle (East)
Mumbai
MAHARASHTRA
400057
India |
| Phone |
91-22-26186052 |
| Fax |
91-22-26151735 |
| Email |
rhjani@zyduscadila.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr RH Jani |
| Designation |
Sr. Vice President, Clinical R&D |
| Affiliation |
|
| Address |
Zydus Cadila House,
Plot No. 360, TPS 5, Service Road, Vile Parle (East)
Mumbai
MAHARASHTRA
400057
India |
| Phone |
91-22-26186052 |
| Fax |
91-22-26151735 |
| Email |
rhjani@zyduscadila.com |
|
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Source of Monetary or Material Support
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| Cadila Healthcare Limited |
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Primary Sponsor
|
| Name |
Cadila Healthcare Limited,
Zydus Tower, Satellite Road, Ahmedabad, Gujarat |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tanvi Shah |
Zydus Research Centre |
Sarkhej-Bavla N. H. No. 8 A,Moraiya-382 213
Ahmadabad
GUJARAT |
91-2717-250801-5
tanvishah@zyduscadila.com |
|
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee - Aditya, Ahmedabad |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
Modification(s)
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| Health Type |
Condition |
| Healthy Human Volunteers |
Peginterferon alfa-2b is indicated for the treatment of chronic hepatitis C in patients |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Peginterferon alpha 2 b |
1 mcg/kg a day |
| Comparator Agent |
Viraferon Peg injection |
1 mcg/kg a day |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| 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 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. |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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An Open list of random numbers |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| 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 constant |
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. |
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Secondary Outcome
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| Outcome |
TimePoints |
| NIL |
NIL |
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Target Sample Size
|
Total Sample Size="50"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
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Phase of Trial
|
Phase 1 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
30/08/2010 |
| Date of Study Completion (Global) |
Date Missing |
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Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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Peginterferon alpha 2 b injection formulation is being developed by M/s. Cadila Healthcare Ltd. This study is being conducted to evaluate the pharmacodynamics and pharmacokinetics of the product of Cadila Healthcare Ltd. in comparison to the existing formulation of Schering Plough, Ireland. And also to evaluate the safety and tolerability of Peginterferon alpha 2 b in healthy human subjects. Subjects will undergo a screening procedure at least once within 21 days prior to dosing. Upon entering into the study, the subjects will be housed in the clinical facility of the trial site from at least 10 hours before dosing till 48 hours post-dose blood sampling. |