Status:
COMPLETED
Increasing Dose Study of Pramipexole in Two-way Cross-over Comparison of ER Tablet Versus IR Tablet in Japanese Healthy Male Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
20-40 years
Phase:
PHASE1
Brief Summary
The objectives of this study were to investigate relative BA at steady state and to investigate dose proportionality of pharmacokinetic parameters Relative BA at steady state: * Pramipexole 0.375 mg...
Eligibility Criteria
Inclusion
- All subjects participating in the study are healthy male volunteers
- Age between 20 and 40 years
- Body mass index (BMI) between 17.6 and 26.4 kg/m2
- All volunteers must give written informed consent before screening to participate in this study and before first drug administration on Day 1 at Visit 2
Exclusion
- Any findings of the medical examination (including blood pressure, pulse rate, ECG, and laboratory test parameters) of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy), psychiatric disorders or neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Chronic or 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 hours) within at least one month or less than ten half-lives of the respective drug before the administration of investigational products
- Use of any drugs which might influence the results of the trial within 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 4 months before the start of drug administration)
- Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day and who cannot refrain from smoking at the trial site)
- Alcohol abuse (\>40 g/day)
- Drug abuse
- Blood donation (≥100 mL within 4 weeks before drug administration or during the trial)
- Excessive physical activities from 7 days before the start of drug administration to the end of this study
- 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
- The following exclusion criteria are of special interest for this study:
- Hypersensitivity to pramipexole or other dopamine agonists
- Supine blood pressure at screening of systolic \<110 mmHg and diastolic \<60 mmHg
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02264132
Start Date
September 1 2006
Last Update
October 15 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.