Multiple Dose Bioequivalence Study of Pramipexole Extended Release in Chinese Healthy Male Volunteers

Launched by BOEHRINGER INGELHEIM · Oct 1, 2010

Keywords

ClinConnect Summary

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Gender

MALE

Eligibility criteria

• Inclusion criteria:
• 1. Healthy males according to the following criteria:
• • Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, clinical laboratory tests
• • 2. Age older than or equal 18 and Age younger than or equal 40 years
• • 3. Body Mass Index larger than or equal 19 and Body Mass Index less than or equal 24kg/m2
• • 4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation.
• Exclusion criteria:
• • 1. Any finding of the medical examination (including Pulse Rate and electrocardiogram) deviating from normal and of clinical relevance
• • 2. Any evidence of a clinically relevant concomitant disease
• • 3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• • 4. Surgery of the gastrointestinal tract (except appendectomy)
• • 5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• • 6. History of relevant orthostatic hypotension, fainting spells or blackouts.
• • 7. Chronic or relevant acute infections
• • 8. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• • 9. Intake of drugs with a long half-life (longer than 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
• • 10. Use of drugs which might reasonably influence the results of the trial up to 7 days before the start of drug administration in the study or during the study period
• • 11. Participation in another trial with an investigational drug within one months prior to administration or during the trial
• • 12. Smoker (more than 10 cigarettes or more than 3 cigars or more than 3 pipes/day)
• • 13. Inability to refrain from smoking on trial days
• • 14. Alcohol abuse (more than 40 g/day)
• • 15. Drug abuse
• • 16. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
• • 17. Excessive physical activities (within one week prior to administration or during the trial)
• • 18. Any laboratory value outside the reference range that is of clinical relevance
• • 19. Any positive results in hepatitis B surface antigen (HBsAg), anti hepatitis B core (HBc) antibodies, anti hepatitis C virus (HCV) antibodies and human immunodeficiency virus (HIV) test
• Exclusion criteria specific for this study:
• • 20. Hypersensitivity to pramipexole or other dopamine agonists
• • 21. Supine blood pressure at screening of systolic\<100 mmHg and diastolic \< 60 mmHg, or symptomatic orthostatic hypotension (i. .e. clinical symptoms of orthostatic hypotension associated with a decline \>=20 mmHg in systolic BP and a decline \>=10 mmHg in diastolic BP, at one minute after standing compared to the previous supine systolic and diastolic BP obtained after 5 minutes of quiet rest)