A Study in Healthy People to Compare Two Different Sifrol® Tablets
- Conditions
- Healthy
- Registration Number
- NCT06457204
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Healthy male or female subjects according to the assessment of the investigator, as<br> based on a complete medical histo1y including a physical examination, vital signs<br> (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and<br> clinical laboratory tests<br><br> 2. Age of 18 to 55 years (inclusive)<br><br> 3. Body mass index (BMI) of 18.5 to 29.9 kg/m² (inclusive)<br><br> 4. Signed and dated written informed consent in accordance with ICH-GCP and local<br> legislation prior to admission to the trial Further inclusion criteria apply.<br><br>Exclusion Criteria:<br><br> 1. Any finding in the medical examination (including BP, PR or ECG) deviating from<br> normal and assessed as clinically relevant by the investigator<br><br> 2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg,<br> diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside<br> the range of 45 to 90 beats per minute (bpm)<br><br> 3. Any laboratory value outside the reference range that the investigator considers to<br> be of clinical relevance<br><br> 4. Any evidence of a concomitant disease assessed as clinically relevant by the<br> investigator Further exclusion criteria apply.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz);Maximum measured concentration of the analyte in plasma (Cmax)
- Secondary Outcome Measures
Name Time Method Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-8)