Clinical trial NCT02261090: Bioavailability of Different Pramipexole Slow-release Formulations Compared to Immediate-release Tablet in Healthy Male Volunteers
Official title: A Multiple Dose Seven-way Cross-over Formulation-finding Study Comparing the Oral Bioavailability of Seven Prototype Slow-release Formulations With 0.75 mg Pramipexole (Four Days Each) to Immediate-release Tablets at Steady State in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-10
Enrollment: 14
Sex: MALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study to compare the oral bioavailability of seven prototype slow-release formulations to immediate-release tablets


Eligibility criteria: 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

Primary outcomes:
measure: Plasma total exposure (AUCτ,ss)
timeFrame: up to 168 hours after each drug administration
measure: Urine total exposure (Aeτ,ss)
timeFrame: up to 168 hours after each drug administration
measure: Plasma maximum exposure (Cmax,ss)
timeFrame: up to 168 hours after each drug administration
measure: Plasma minimum exposure (Cmin,ss)
timeFrame: up to 168 hours after each drug administration
measure: Plasma average concentration (Cavg)
timeFrame: up to 168 hours after each drug administration
measure: Plasma peak to trough fluctuation (PTF)
timeFrame: up to 168 hours after each drug administration
Secondary outcomes:
measure: AUC0-6,11 for the immediate release (IR) formulation
timeFrame: day 7 of visit 2
measure: Cmax for the IR formulation
timeFrame: up to 168 hours after drug administration in visit 2
measure: Cmin for the IR formulation
timeFrame: up to 168 hours after drug administration in visit 2
measure: tmax for the IR formulation
timeFrame: up to 168 hours after drug administration in visit 2
measure: Urinary excretion (Ae) for the IR formulation
timeFrame: up to 168 hours after drug administration in visit 2
measure: tmax,4 for the SR formulation
timeFrame: up to 96 hours after drug administration in visit 3-5, 7 and 9
measure: t1/2,4 for the SR formulation
timeFrame: up to 96 hours after drug administration in visit 9
measure: Urinary excretion (Ae) for the SR formulation
timeFrame: up to 168 hours after drug administration
measure: Number of subjects with adverse events
timeFrame: up to 8 days after last drug administration
measure: Number of subjects with clinically significant findings in laboratory tests
timeFrame: up to 8 days after last drug administration
measure: Number of subjects with clinically significant findings in vital signs
timeFrame: up to 8 days after last drug administration
measure: Assessment of global tolerability by investigator on a 5-point scale
timeFrame: at the end of each of the visits 2 to 9
Other outcomes:
Locations:
Study officials:
References: