Clinical trial NCT02260024: In Vitro/in Vivo Correlation (IVIVC) for Oral Slow Release (SR) Tablets Pramipexole in Healthy Male Volunteers
Official title: A Single Dose Five-way Cross-over Study to Establish an in Vitro/in Vivo Correlation (IVIVC) for Oral Slow Release (SR) Tablets With 0.375 mg Pramipexole in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-09
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of the study was to estimate the magnitude of the error in the prediction of in vivo bioavailability (AUC0-30,Cmax) by means of in vitro dissolution data applying the methods of IVIVC. The secondary objective of the study was to investigate whether the intake of food 30 minutes prior to drug administration affects the systemic exposure of pramipexole SR C2 or not


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects as determined by results of the screening
* Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
* Age ≥ 18 and ≤ 50 years
* BMI ≥ 18.5 and ≤ 29.9 kg/m2

Exclusion Criteria:

* Hypersensitivity to pramipexole or to other dopamine agonists
* Supine systolic blood pressure lower than 110 mmHg and supine diastolic blood pressure lower than 60 mmHg at screening
* 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

Primary outcomes:
measure: AUC0-30 (area under the concentration time curve of pramipexole in blood plasma over the time interval 0 to 30 h after drug administration)
timeFrame: Up to 30 hours after drug administration
measure: Cmax (maximum measured concentration of pramipexole in blood plasma)
timeFrame: Up to 30 hours after drug administration
Secondary outcomes:
measure: AUC0-10 (area under concentration-time curve of pramipexole in blood plasma over the time interval from 0 to the median tmax in the fasted state)
timeFrame: Up to 30 hours after drug administration
measure: AUC0-24 (area under concentration-time curve of pramipexole in blood plasma over the time interval from 0 to 24 h after drug administration),
timeFrame: Up to 24 hours after drug administration
measure: AUC0-∞ (area under the concentration-time curve of pramipexole in blood plasma over the time interval from 0 extrapolated to infinity),
timeFrame: Up to 30 hours after drug administration
measure: tmax (time from dosing to the maximum concentration of pramipexole in blood plasma)
timeFrame: Up to 30 hours after drug administration
measure: λz (terminal rate constant in blood plasma),
timeFrame: Up to 30 hours after drug administration
measure: t½ (terminal half-life of pramipexole in blood plasma)
timeFrame: Up to 30 hours after drug administration
measure: MRTpo (mean residence time of pramipexole in the body after oral administration)
timeFrame: Up to 30 hours after drug administration
measure: CL/F (apparent clearance of pramipexole in the blood plasma after extravascular administration)
timeFrame: Up to 30 hours after drug administration
measure: Vz/F (apparent volume of distribution during the terminal phase (λz) following an extravascular dose)
timeFrame: Up to 30 hours after drug administration
measure: Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)
timeFrame: Up to 120 hours after drug administration
measure: Number of subjects with adverse events
timeFrame: Up to 7 days after last drug administration
measure: Number of subjects with clinically significant findings in vital signs
timeFrame: Up to 7 days after last drug administration
measure: Number of subjects with clinically significant findings in laboratory parameters
timeFrame: Up to 7 days after last drug administration
measure: Number of subjects with clinically significant findings in physical examination
timeFrame: Up to 7 days after last drug administration
Other outcomes:
Locations:
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