| CTRI Number |
CTRI/2014/01/004288 [Registered on: 06/01/2014] Trial Registered Prospectively |
| Last Modified On: |
12/06/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
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Type of Study
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| Study Design |
Randomized, Crossover Trial |
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Public Title of Study
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Bioequivalence of Pramipexole Extended Release Tablets |
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Scientific Title of Study
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A multi-centre randomized, open-label, two treatment, two sequence, crossover study to evaluate the bioequivalence of Pramipexole dihydrochloride Extended Release Tablets (2.25 mg and 4.5 mg) of Mylan Laboratories Ltd., India compared to Sifrol® ER Tablets (2.25 mg and 4.5 mg) of Boehringer Ingelheim International GmbH, in Parkinson’s disease patients |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| C-MYL-PRA-001 Version:00 Dated:01 Aug 2013 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Vemula Sreekanth |
| Designation |
Medical Expert |
| Affiliation |
ClinSync Clinical Research Pvt. Ltd. |
| Address |
#4-1-1, Hayathnagar
Hyderabad
ANDHRA PRADESH
501505
India |
| Phone |
91-9848170120 |
| Fax |
|
| Email |
vemula.srikanth@clinsynccro.com |
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Details of Contact Person
Public Query
|
| Name |
Dr V Satya Suresh Attili |
| Designation |
Director |
| Affiliation |
ClinSync Clinical Research Pvt. Ltd. |
| Address |
#4-1-1 Hayathnagar
Hyderabad
ANDHRA PRADESH
501505
India |
| Phone |
91-9246243034 |
| Fax |
040-24203000 |
| Email |
attili@clinsynccro.com |
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Source of Monetary or Material Support
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| Mylan Laboratories Limited,
Clinical Research Centre, Saradhi Chambers,
Plot No. 4-A, Beside Poulomi Hospital,
Rukminipuri, Dr. A. S. Rao Nagar,
Hyderabad 500062.
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Primary Sponsor
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| Name |
Mylan Laboratories Limited |
| Address |
Clinical Research Centre, Saradhi Chambers,
Plot No. 4-A, Beside Poulomi Hospital,
Rukminipuri, Dr. A. S. Rao Nagar,
Hyderabad 500062
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| Type of Sponsor |
Pharmaceutical industry-Indian |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ummer Karadan |
Baby Memorial Hospital Ltd. |
Indira Gandhi Road, Calicut-673004
Kozhikode
KERALA |
09447843954
ummerneuro@yahoo.co.in |
| Dr Gururaj Pramod |
Bibi General Hospital & Cancer Center |
16-3-991/1/C, Govt. Printing Press Road, Malakpet, Hyderabad-500024
Hyderabad
ANDHRA PRADESH |
09908649700
drgururaj@gmail.com |
| Dr Bhaskar Rao |
Mediciti Hospitals |
5-9-22, Secretariat Road, Hyderabad-500063
Hyderabad
ANDHRA PRADESH |
09866439933
bhaskar3258@gmail.com |
| DrSCMukherjee |
Nightingale Hospital |
Clinical Research Room No.302,
11 Shakespeare Sarani Kolkata-700071
Kolkata
WEST BENGAL |
91-9830413617
033-22826454
drscmukherjee@gmail.com |
| Dr Rupam Borgohain |
Nizams Institute of Medical Sciences |
Panjagutta, Hyderabad-500082
Hyderabad
ANDHRA PRADESH |
09866191476
b_rupam@hotmail.com |
| DrPrashant Kumar Singh |
Sita Devi Hospital |
Dept. of Neurology, Basement OPD Section,
Behind Chambal Grid Hawa Sadak Jaipur
Jaipur
RAJASTHAN |
91-9461669549
0141-2211372
drprashantbh80@gmail.com |
| DrPahari Ghosh |
Sri Aurobindo Seva Kendra |
Neurology Clinical Trial Room,Room No.114,
1H, Gariahat road(South), Jodhpur Park, Kolkata-700068
Kolkata
WEST BENGAL |
03324990059
03324990059
ghosh.pahari@gmail.com |
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Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| BIBI Institutional Ethics Committee |
Approved |
| Institution Ethics Committee Sita Devi Hospital |
Approved |
| Institutional Ethics Committee Baby Memorial Hospital Ltd. |
Approved |
| Institutional Ethics Committee Nightingale Hospital |
Approved |
| Institutional Ethics Committee Sri Aurobindo Seva Kendra |
Approved |
| Mediciti Ethics Committee |
Approved |
| NIMS Institutional Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Parkinson’s Disease , |
|
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Pramipexole dihydrochloride 2.25mg and 4.5mg |
Dose-2.25mg and 4.5mg, Frequency- Once Daily, Route of Administration-Oral, Total Duration of Therapy-12 Days Manufactured by Mylan Laboratories Ltd., |
| Comparator Agent |
Sifrol |
Dose-2.25mg and 4.5mg, Frequency-Once Daily, Route of Administration-Oral, Total Duration of Therapy-12 Days Manufactured by Boehringer Ingelheim International GmbH |
|
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Inclusion Criteria
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| Age From |
30.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with idiopathic Parkinson’s disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
2.Subjects 30 years of age or older at the time of diagnosis.
3.Subjects already receiving pramipexole 2.25 mg as total daily dose either as immediate release formulation or extended release formulation for Part A of the study and Patients already receiving pramipexole 4.5 mg as total daily dose either as immediate release formulation or extended release formulation for Part B of the study
4.Subjects eligible to receive 2.25 mg with respect to his current clinical condition as per principal investigators discretion will be enrolled in Part A of the study and patients eligible to receive 4.5 mg with respect to his current clinical condition as per principal investigators discretion will be enrolled in Part B of the study
5.Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
6.Subjects with a Creatinine clearance > 60 mL/min
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| ExclusionCriteria |
| Details |
1.Clinically relevant abnormal vital sign values or safety laboratory data.
2.History of psychosis, except history of drug induced hallucinations
3.Clinically significant electrocardiogram (ECG) abnormalities.
4.Clinically significant hypotension either at screening visit or at visit, Day -1.
5.Malignant melanoma or history of previously treated malignant melanoma.
6.Any other clinically significant disease
7.Pregnancy or breast-feeding.
8.Sexually active female of childbearing potential
9.Serum levels of Aspartate Aminotransferase (Serum Glutamic Oxaloacetic Transaminase) (AST (SGOT)), Alanine Aminotransferase (Serum Glutamate Pyruvate Transaminase) (ALT (SGPT)), alkaline Phosphatase and bilirubin > 2 Upper Limit of Normal (ULN) (on screening lab test).
10.Known hypersensitivity to Pramipexole or its excipients.
11.Drug abuse (including alcohol), according to Investigator’s judgment, within 2 years prior to screening.
12.Participation in other investigational drug studies or use of other investigational drugs within 4 weeks or five times the half-life of the investigational drug (whichever is longer) prior to visit, Day -1.
13.Any other condition or abnormal findings that, in the investigator’s judgment, might increase the risk to the subject or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study
14.Subject with a history of difficulty in donating blood or difficulty in accessibility of veins
15.Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drug, or which may jeopardize the subject in case of participation in the study.
16.Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing or longer if required by local regulation.
17.Significant illness within the two weeks prior to dosing or any active systemic infection or medical condition that may require treatment or therapeutic intervention during the study.
18.Current history of active systemic bacterial, viral or fungal infections
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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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Pharmacy-controlled Randomization |
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Blinding/Masking
|
Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| To characterize the pharmacokinetic profiles of Pramipexole at steady state under fasting condition and to study the effect of food in steady state under fed condition following once daily administration of PPX ER 2.25 mg and 4.5mg tablets and also to assess the bioequivalence of Pramipexole between the Test product and Reference product at steady state in fed and fasting conditions. |
Baseline to End of Study |
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Secondary Outcome
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| Outcome |
TimePoints |
| To assess the safety and tolerability of PPX ER 2.25 mg and 4.5mg tablets following once daily oral administration at steady state under fasting and fed condition. |
Baseline to End of Study |
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Target Sample Size
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Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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N/A |
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Date of First Enrollment (India)
|
10/01/2014 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
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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
|
Multicenter, randomized, open-label, two treatment, two
sequence, crossover bioequivalence study of Pramipexole dihydrochloride
Extended Release Tablets (2.25 mg and 4.5 mg) in
Parkinson’s disease patients. |