Health Condition 1: null- Idiopathic Parkinsonâ??s disease
Conditions
Interventions
Intervention1: Pramipexole Prolonged Release Tablets
3.15 mg Mylan Laboratories Ltd: Once daily. Oral tablet
Control Intervention1: Sifrol® 3.15 mg depottabletter
(depot tablet)Boehringer Ingelheim
Sponsors
MYLAN LABORATORIES LIMITED INDIA
Cliantha Research Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects with Parkinsonâ??s disease 30 years of age or older at the time of diagnosis. 2. Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. 3. Subjects with a Creatinine clearance > 60 mL/min. 4. Patients with Body Mass Index (BMI) greater than or equal to 18.5 but less than or equal to 30. 5. Subject should be judged eligible by the principal investigator or co-investigator or physician during a pre-study safety assessment performed within 21 days of the first dose of study medication. 6. Signed and dated written informed consent prior to admission to the study in accordance with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) and the local regulatory requirements.
Exclusion criteria
Exclusion criteria: Patients presenting with any of the following will be excluded from the study: 1. History of allergy or hypersensitivity reactions to Pramipexole or the ingredients of the formulation. History of lack of efficacy and/or safety events (i.e. adverse event) following use of Pramipexole or the ingredients of the formulation. 2. Use of medications that may cause secondary Parkinsonism, including but not limited to: Neuroleptics, Metoclopramide, ô??®-methyldopa, Flunarizine, Methylphenidate, Cinnarizine, Reserpine, or Amphetamines in the last 6 months prior to randomization. 3. Signs or symptoms suggesting other Parkinson syndromes (e.g. Atypical parkinsonian syndromes) 4. Presence of Dementia by DSM IV criteria or a Mini Mental State Examination score 5. History of psychosis, except history of drug induced hallucinations 6. Clinically significant electrocardiogram (ECG) abnormalities during screening. 7. Clinically significant hypotension either at screening visit or at check-in visit. 8. Malignant melanoma or history of previously treated malignant melanoma. 9. History of epilepsy or psychosis or any other clinically significant disease within the last 1 year of randomization 10. Females who are pregnant, breast-feeding, planning to become pregnant or sexually active females of child bearing potential who donâ??t follow contraceptive requirements 11. Serum levels of AST (SGOT), ALT (SGPT), alkaline Phosphatase and bilirubin > 2 X Upper Limit of Normal (ULN) (on screening lab test). 12. Alcohol or drug abuse (including alcohol), according to Investigatorâ??s judgment, within 6 months prior to screening. 13. Consumption of grapefruit, grapefruit-like or grapefruit containing products within 7 days of drug administration. 14. Use of enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication including but not limited to: Cimetidine, Amantadine, Mexiletine, Zidovudine, Cisplatin, Quinine and Procainamide. They can be allowed depending on Principal Investigatorâ??s discretion in consultation with Medical monitor, if they are kept constant in the last 30 days and are expected to remain constant during the study period 15. Subject with a history of difficulty in donating blood or difficulty in accessibility of veins 16. Donation or loss of 450 mL or more of blood within 2 months prior to dosing. 17. Current history of active systemic bacterial, viral or fungal infections. 18. Any clinically significant systemic disease or medical condition that may require treatment or therapeutic intervention during the study. 19. Participation in other investigational drug studies or use of other investigational drugs within 30 days prior to randomization. 20. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drug 21. Any other condition or abnormal findings that, in the investigatorâ??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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| On days 5 and 6: (steady state, fasting and fed PK): Cmax,ss, Ctss, and AUCtau,ssTimepoint: In each period, Day 05, total 12 venous blood samples will be collected at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 and 24 hours post-dose. In each period, Day 06, total 13 venous blood samples will be collected at 2, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 18 and 24 hours post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Chirag Shah
Cliantha Research Limited
Outcome results
None listed