Healthy
Conditions
Brief summary
Study to compare the oral bioavailability of seven prototype slow-release formulations to immediate-release tablets
Interventions
DRUGFormulation B: Pramipexole Slow release (SR) tablet
DRUGFormulation C: Pramipexole Slow release tablet
DRUGFormulation D: Pramipexole Slow release tablet
DRUGFormulation E: Pramipexole Slow release tablet
DRUGFormulation F: Pramipexole Slow release tablet
DRUGFormulation G: Pramipexole Slow release tablet
DRUGFormulation H: Pramipexole Slow release tablet
DRUGPramipexole immediate release (IR) tablets
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
21 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma total exposure (AUCτ,ss) | up to 168 hours after each drug administration |
| Urine total exposure (Aeτ,ss) | up to 168 hours after each drug administration |
| Plasma maximum exposure (Cmax,ss) | up to 168 hours after each drug administration |
| Plasma minimum exposure (Cmin,ss) | up to 168 hours after each drug administration |
| Plasma average concentration (Cavg) | up to 168 hours after each drug administration |
| Plasma peak to trough fluctuation (PTF) | up to 168 hours after each drug administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| t1/2,4 for the SR formulation | up to 96 hours after drug administration in visit 9 | — |
| Urinary excretion (Ae) for the SR formulation | up to 168 hours after drug administration | — |
| Number of subjects with adverse events | up to 8 days after last drug administration | — |
| AUC0-6,11 for the immediate release (IR) formulation | day 7 of visit 2 | — |
| Number of subjects with clinically significant findings in vital signs | up to 8 days after last drug administration | blood pressure, pulse rate |
| Assessment of global tolerability by investigator on a 5-point scale | at the end of each of the visits 2 to 9 | — |
| Number of subjects with clinically significant findings in laboratory tests | up to 8 days after last drug administration | — |
| Cmax for the IR formulation | up to 168 hours after drug administration in visit 2 | — |
| Cmin for the IR formulation | up to 168 hours after drug administration in visit 2 | — |
| tmax for the IR formulation | up to 168 hours after drug administration in visit 2 | — |
| Urinary excretion (Ae) for the IR formulation | up to 168 hours after drug administration in visit 2 | — |
| tmax,4 for the SR formulation | up to 96 hours after drug administration in visit 3-5, 7 and 9 | — |
Outcome results
None listed