Healthy
Conditions
Brief summary
The goal of this study is to find out whether pramipexole tablets made at two different production sites are handled in the same way by the body.
Interventions
DRUGSifrol®
Pramipexole tablets
DRUGMirapex®
Pramipexole tablets
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male or female trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), and 12-lead electrocardiogram (ECG) 2. Age of 18 to 55 years (inclusive) 3. Body mass index (BMI) of 18.5 to 29.9 kg/m\^2 (inclusive) 4. Signed and dated written informed consent in accordance with international council for harmonisation - good clinical practice (ICH-GCP) and local legislation prior to admission to the trial 5. Further inclusion criteria apply.
Exclusion criteria
1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator 2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimeters of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm) 3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance 4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator 5. Further
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) | Up to Day 11 |
| Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss) | Up to Day 11 |
Secondary
| Measure | Time frame |
|---|---|
| Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss) | Up to Day 11 |
| Time from dosing to minimum measured concentration of the analyte in plasma at steady state within a uniform dosing interval τ (tmin,ss) | Up to Day 11 |
| Time from last dosing to maximum concentration of the analyte in plasma at steady state (tmax,ss) | Up to Day 11 |
| Average concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cavg) | Up to Day 11 |
| Measured concentration of the analyte in plasma at steady state at timepoint (= end of interval) τ (Cτ,ss) | Up to Day 11 |
| Peak-trough fluctuation (PTF) | Up to Day 11 |
| Peak-trough swing (PTS) | Up to Day 11 |
Countries
Germany
Outcome results
None listed