Health Condition 1: null- Parkinsonâ??s Disease
Conditions
Interventions
Intervention1: Pramipexole prolonged release tablet: Pramipexole prolonged release tablet,
dose- 3.15 mg, Frequency- once daily, Route of Administration-Oral, Total Duration of Therapy-14 Days Manufa
Sponsors
ACTAVIS Inc
Lotus Labs Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Must be willing and able to give Informed Consent. 2. Must be 30 years to 75 years of age at Baseline. 4. Should be on a stable regimen of pramipexole and eligible to receive 3.15 mg of pramipexole (including dose titration, if required clinically)for treatment of Parkinson disease. 5. Must have a negative urine pregnancy test at the Screening Visit and use an adequate contraceptive method throughout the study if the patient is a woman of child-bearing potential. Women who are surgically sterile (hysterectomy or tubal ligation) or whose last menstruation was 12 months or more prior to the Screening Visit are considered to be of non-child-bearing potential. Acceptable forms of contraception include oral, implanted, or injected contraceptives intrauterine devices in place for at least 3 months estrogen patch and adequate barrier methods in conjunction with spermicide. Abstinence is considered an acceptable contraceptive regimen. 6. Must be willing and able to comply with trial procedures.
Exclusion criteria
Exclusion criteria: 1. Signs or symptoms suggesting other Parkinsonian syndromes. 2. Use of medications that may cause secondary Parkinsonism, including but not limited to: Neuroleptics, Metaclopramide, Alphamethyldopa, Flunarizine, Methylphenidate, Cinnarizine, Reserpine, Or Amphetamines in the last 6 months prior to Baseline Visit. 3. Presence of Dementia by Diagnostic and Statistical Manual of Mental Disorders IV criteria or a Mini Mental State Examination score 4. History of psychosis, except history of drug induced hallucinations 5. Active Epilepsy (i.e., occurrence of a Seizure) within the past year prior to Baseline Visit. 6. Myocardial Infarction within previous 6 months prior to Baseline Visit. 7. Third degree Atrioventricular block or Sick Sinus Syndrome.Clinically significant renal disease (Uncontrolled Diabetes Mellitus and Hypertension). 8. Any other clinically significant medical or psychiatric condition (e.g., angina, active neoplasm) that in the judgment of the investigator would interfere with the patientâ??s ability to participate in the study or would jeopardize safe conduct of the study. 9. Patients who are currently pregnant or planning pregnancy during the study, or lactating; 10. Known hypersensitivity or intolerability to Pramipexole. 11. Participating in other drug studies or receiving other experimental medications within 30 days of Baseline Visit. 12. History of drug or alcohol dependency within 6 months of baseline visit. 13. Patient positive for alcohol breath test, urine drug screening, HIV, VDRL/RPR, Hepatitis B & C tests 14. Patient previously been enrolled into this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measures in this study are derived PK parameters obtained from concentration data derived from the total plasma drug concentrations. Cmax(ss), Cmin(ss), Cavg(ss), Cpd, tmax(ss), AUCÏ?(ss), Fluctuation, Swing, t1/2(ss),Kel(ss) will be assessed.Timepoint: 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome assessment of safety will be performed for all patients who receive at least one dose or part dose of investigational product and for whom at least one post-dose safety observation is recorded (the Safety Population). Safety data that will be evaluated include adverse events (including changes from baseline in physical examination findings), clinical laboratory results, vital signs and ECGs.Timepoint: 06 | — |
Countries
India
Contacts
Public ContactDr Nagashayana G
Lotus Labs Pvt. Ltd.,
Outcome results
None listed