Status:
COMPLETED
Multiple Dose Bioequivalence Study of Pramipexole Extended Release in Chinese Healthy Male Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
18-40 years
Phase:
PHASE1
Brief Summary
To establish bioequivalence at steady state of: 1)0.375 mg pramipexole extended release tablet q.d. in fasted status versus 0.125 mg pramipexole Immediate release tablet t.i.d. in fasted status 2)1.5...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Age older than or equal 18 and Age younger than or equal 40 years
- Body Mass Index larger than or equal 19 and Body Mass Index less than or equal 24kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation.
- Exclusion criteria:
- Any finding of the medical examination (including Pulse Rate and electrocardiogram) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts.
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- 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
- 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
- Participation in another trial with an investigational drug within one months prior to administration or during the trial
- Smoker (more than 10 cigarettes or more than 3 cigars or more than 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 40 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance
- 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:
- Hypersensitivity to pramipexole or other dopamine agonists
- 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)
Exclusion
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01214109
Start Date
December 1 2010
Last Update
June 27 2014
Active Locations (1)
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1
248.665.86002 Boehringer Ingelheim Investigational Site
Beijing, China