Status:
COMPLETED
Bioavailability of Different Pramipexole Slow-release Formulations Compared to Immediate-release Tablet in Healthy Male Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
21-50 years
Phase:
PHASE1
Brief Summary
Study to compare the oral bioavailability of seven prototype slow-release formulations to immediate-release tablets
Eligibility Criteria
Inclusion
- All participants in the study should be healthy males
- Participants should be ranging from 21 to 50 years of age
- Body mass index (BMI) within 18.5 to 29.9 kg/m2
- In accordance with Good Clinical Practice and the local legislation all volunteers will have given their written informed consent prior to admission to the study
Exclusion
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Intake of drugs with a long half-life (\> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
- Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
- Participation in another trial with an investigational drug (≤ two months prior to administration or during the trial)
- Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
- Inability to refrain from smoking on in-house trial days
- Alcohol abuse (\> 60 g/day)
- Drug abuse
- Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)
- Any laboratory value outside the clinically accepted reference range
- Excessive physical activities within the last week before the trial or during the trial
- Hypersensitivity to pramipexole, or other dopamine agonists
- Supine blood pressure at screening of systolic \< 110 mmHg and diastolic \< 60 mmHg
- A haemoglobin value at screening of less than 13.5 g/dl (usual lower limit of normal for males: 12.6 g/mL)
- Subjects involved in passenger transport or operation of dangerous machines
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT02261090
Start Date
June 1 2004
Last Update
October 10 2014
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